The Anspach Effort, Inc.
Medical device manufacturer in Palm Beach Gardens, FL.
60510(k) clearances
0PMA approvals
302recalls
Device types
- HBE Drills, Burrs, Trephines & Accessories… 7
- HSZ Instrument, Surgical, Orthopedic, Pneumatic… 4
- MBI Fastener, Fixation, Nondegradable, Soft… 4
- HRX Arthroscope 4
- HBB Motor, Drill, Pneumatic 3
- GEY Motor, Surgical Instrument, Ac-Powered 3
- ERL Drill, Surgical, Ent (Electric Or… 3
- HBC Motor, Drill, Electric 3
- HBF Drills, Burrs, Trephines & Accessories… 2
- GAD Retractor 2
- FWZ Operating Room Accessories Table Tray 2
- HTO Reamer 1
- HTC Pliers, Surgical 1
- KKX Drape, Surgical, Antimicrobial 1
- KQM Camera, Surgical And Accessories 1
- FXR Holder, Camera, Surgical 1
- FZS Curette, Surgical, General Use 1
- HTT Burr, Orthopedic 1
- CCX Support, Patient Position 1
- HWE Instrument, Surgical, Orthopedic… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…HBC · Traditional | 05/19/2022SE |
| K183545 | Anspach Helix Dissection ToolsHBE · Traditional | 07/19/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | 03/27/2018SE |
| K133604 | Anspach EG1 High Speed System, G1 AttachmentsHBC · Special | 01/10/2014SE |
| K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemERL · Traditional | 12/31/2013SE |
| K113476 | Anspach Dissection ToolsHBE · Special | 12/16/2011SE |
| K082637 | Cranial PerforatorHBF · Traditional | 12/22/2008SE |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…HBE · Special | 04/30/2008SE |
| K061297 | Anspach Imri Safe Surgical Drill SystemHBB · Traditional | 01/26/2007SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | 01/16/2007SE |
| K052572 | Anspach Knotless AnchorMBI · Traditional | 12/05/2005SE |
| K050628 | Anspach CouplerHBE · Traditional | 04/07/2005SE |
| K042783 | Anspach Minimal Access Spinal Attachment (Masa) SystemHBE · Traditional | 12/17/2004SE |
| K040186 | Anspach MRI Safe Surgical Drill SystemHBB · Traditional | 04/15/2004SE |
| K040076 | Anspach Advanced Micro Saw AttachmentsHBE · Traditional | 03/15/2004SE |
| K030576 | Anspach Irrigation Pump and Irrigation Pump IIFRN · Traditional | 05/21/2003SE |
| K022907 | Anspach Powered Kerrison System (PKS)HAD · Traditional | 10/21/2002SE |
| K011444 | Anspach Emax Drill SystemHBC · Traditional | 08/08/2001SE |
| K002903 | Anspach Angled Micronose AttachmentHBE · Traditional | 10/24/2000SE |
| K982991 | Anspach Access Cranial PerforatorHBF · Traditional | 10/21/1998SE |
| K981688 | Anspach Suture AnchorMBI · Traditional | 07/13/1998SE |
| K974025 | Anspach Shielded AttachmentGFF · Traditional | 07/06/1998SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | 05/05/1997SE |
| K965069 | Anspach Suture AnchorMBI · Traditional | 02/12/1997SE |
| K965080 | Anspach Micromax SystemERL · Traditional | 01/10/1997SE |
| K963686 | Anspach Suture Anchor (Modified)MBI · Traditional | 11/25/1996SE |
| K960630 | Anspahc Speed ReducerHBB · Traditional | 11/19/1996SE |
| K955084 | Aspach 65,000 (Modification)HSZ · Traditional | 01/17/1996SE |
| K945525 | Anspach Suture AnchorHWC · Traditional | 07/11/1995SE |
| K940535 | Auto Lube SystemGEY · Traditional | 03/21/1994SE |
| K921338 | Anspach Mini-Plating SystemHRS · Traditional | 02/10/1993SE |
| K864314 | Eftekhar Rechannelization Drill GuideHSZ · Traditional | 11/19/1986SE |
| K852592 | CO2 for ArthroscopyHRX · Traditional | 08/09/1985SE |
| K850389 | Multiple Outlet ManifoldGEY · Traditional | 03/18/1985SE |
| K841296 | Tube TenderKRI · Traditional | 06/11/1984SE |
| K831756 | Anspach 65,000HSZ · Traditional | 09/29/1983SE |
| K830721 | Wire TwistersHTC · Traditional | 04/12/1983SE |
| K822065 | Kam SuckerKDC · Traditional | 08/16/1982SE |
| K820777 | Mini-Micro Arthroscopic ScapelHRX · Traditional | 05/12/1982SE |
| K820289 | Anthroscopic Surgical TableFWZ · Traditional | 04/21/1982SE |
| K820776 | Cannuoated TrocharHRX · Traditional | 04/15/1982SE |
| K820291 | Knee Support for X-Ray & SurgeryFWZ · Traditional | 03/05/1982SE |
| K820290 | Self Retaining Retractor for Hand SurgGAD · Traditional | 03/05/1982SE |
| K820292 | Extractor III · Traditional | 03/02/1982SE |
| K820293 | Bone Biopsy SetKNW · Traditional | 03/01/1982SE |
| K820275 | Arthroscopic HarpoonHRX · Traditional | 02/12/1982SE |
| K811996 | Gator DrapesKKX · Traditional | 08/13/1981SE |
| K811717 | Gator DrapesKQM · Traditional | 07/20/1981SE |
| K811115 | Superflow Cannula for Arthros. Surgery · Traditional | 07/01/1981SE |
| K811081 | Medullary Canal ScrapersHTO · Traditional | 04/29/1981SE |
| K810303 | Television Camera Holder for SurgeryFXR · Traditional | 02/26/1981SE |
| K803178 | Anspach Menisectomy KnifeFZS · Traditional | 02/13/1981SE |
| K802598 | Carbide Cutting Instrument/IntraarticuHTT · Traditional | 11/19/1980SE |
| K802599 | Arthroscopic Fat Pad RetractorGAD · Traditional | 10/31/1980SE |
| K802271 | The Immobilizer for Open & ArthroscopicBWN · Traditional | 10/23/1980SE |
| K801330 | Anspach Leg SupportCCX · Traditional | 06/26/1980SE |
| K801326 | Anspach Operating Table Support/SpinalEPW · Traditional | 06/26/1980SE |
| K801329 | Anspach Instrument CaddyHSZ · Traditional | 06/09/1980SE |
| K801328 | The EqualizerMDM · Traditional | 06/09/1980SE |
| K801327 | The Extractor I TMHWB · Traditional | 06/09/1980SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-0924-2023 Class II | Pediatric Craniotome Ref:CRANI-P-G1Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0923-2023 Class II | 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref:…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0922-2023 Class II | 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0921-2023 Class II | Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0920-2023 Class II | 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref:…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0919-2023 Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0918-2023 Class II | Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0917-2023 Class II | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0916-2023 Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems.…Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment… | 12/07/2022Open, Classified |
| Z-0398-2018 Class II | OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are…This voluntary recall was initiated because a veterinary unit was physically shipped in error to a… | 09/29/2017Terminated |
| Z-2032-2017 Class II | 20.2cm Heavy Duty Long Heavy Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2031-2017 Class II | Sagittal MICRO-SAWSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2030-2017 Class II | 5.0cm Heavy Duty Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2029-2017 Class II | 5.0cm Short AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2028-2017 Class II | SMALL ATTACHMENT, J-LATCHSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2027-2017 Class II | SMALL ATTACHMENT, JACOBS CHUCKSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2026-2017 Class II | Reciprocating MICRO SAWSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2025-2017 Class II | 7.5cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2024-2017 Class II | 8cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2023-2017 Class II | 14cm QD Angle AttachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2022-2017 Class II | 14cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2021-2017 Class II | 10.5cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2020-2017 Class II | 11cm QD Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2019-2017 Class II | Oscillating MICRO-SAW Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2018-2017 Class II | 90 degree Contra Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2017-2017 Class II | 45 degree Contra Angle Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2016-2017 Class II | Otologic Curved Micro Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2015-2017 Class II | Sagittal Saw Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2014-2017 Class II | 16cm Minimally Invasive Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2013-2017 Class II | 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2012-2017 Class II | 8.0cm Medium Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2011-2017 Class II | Minimal Access Straight Driver Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2010-2017 Class II | Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2009-2017 Class II | Minimal Access Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2008-2017 Class II | Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2007-2017 Class II | Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2006-2017 Class II | Bearing Sleeve, 15CM Straight Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2005-2017 Class II | Bearing Sleeve, 15CM Curved Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2004-2017 Class II | Bearing Sleeve, 10CM Straight Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2003-2017 Class II | Bearing Sleeve, 10CM Curved Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2002-2017 Class II | 10.5cm Long Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2001-2017 Class II | 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2000-2017 Class II | 10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1999-2017 Class II | 11.0cm Long Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1998-2017 Class II | IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1997-2017 Class II | IMRI SHORT ATTACHMENT Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1996-2017 Class II | IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1995-2017 Class II | Keyless Driver Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1994-2017 Class II | Chuck Driver SystemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1993-2017 Class II | Compact Speed Reducer, 60:1 Black MaxSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1992-2017 Class II | Compact Speed Reducer, 60:1Supplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1991-2017 Class II | Pediatric CraniotomeSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1990-2017 Class II | Rotating Large CraniotomeSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1989-2017 Class II | Large Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1988-2017 Class II | Rotating Adult Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1987-2017 Class II | 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1986-2017 Class II | Adult Craniotome Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1985-2017 Class II | 6.8cm Controlled Depth Attachment Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1984-2017 Class II | 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1983-2017 Class II | PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1982-2017 Class II | 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1981-2017 Class II | 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1980-2017 Class II | 6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1979-2017 Class II | B-SAGITTAL ASSEMBLY Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1978-2017 Class II | 26.65CM ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1977-2017 Class II | 7.5CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1976-2017 Class II | 8CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1975-2017 Class II | 13.5CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1974-2017 Class II | 14CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1973-2017 Class II | 10.5CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1972-2017 Class II | 11CM ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1971-2017 Class II | 90 DEG RIGHT ANGLE ATTACH, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1970-2017 Class II | CONTRA ANGLE ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1969-2017 Class II | 9.4CM MICRO REVISION ATTACH, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1968-2017 Class II | 16.5CM MICRO REVISION ATTACH, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1967-2017 Class II | 22CM MICRO REVISION ATTACH, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1966-2017 Class II | KEYLESS DRIVER, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1965-2017 Class II | 16CM MIN INVASIVE ATTACH, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1964-2017 Class II | ADJUSTABLE DRILL GUIDE, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1963-2017 Class II | GREEN ROTATING CRANIOTOME, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1962-2017 Class II | STANDARD CRANIOTOME, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1961-2017 Class II | LARGE CRANIOTOME, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1960-2017 Class II | 11.25CM ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1959-2017 Class II | 19CM ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1958-2017 Class II | 7.2cm Adjustable Drill Guide Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1957-2017 Class II | System Console, Single Port, no irrigationSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1956-2017 Class II | System Console, Single Port, with irrigation Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1955-2017 Class II | Console, eMax2 Plus Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1954-2017 Class II | Foot Control without Switches, SC2100 Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1953-2017 Class II | Foot Control, SC2100 Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1952-2017 Class II | eMax2 PLUS Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1951-2017 Class II | eMax2 Hybrid Hand Control Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1950-2017 Class II | eMax2 Motor Assembly Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1949-2017 Class II | Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric…Supplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1948-2017 Class II | Electronic Foot Control with Direction Switch Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1947-2017 Class II | Electric Handpiece EM Hand Control Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1946-2017 Class II | Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric…Supplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1945-2017 Class II | XMAX Motor, High Strength Hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1944-2017 Class II | XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1943-2017 Class II | IMRI MOTOR Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1942-2017 Class II | IMRI AIR CONTROL Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1941-2017 Class II | BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1940-2017 Class II | 19cm Attachment, Black Max Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1939-2017 Class II | Autolube-III with NK Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1938-2017 Class II | Autolube-III with Irrigation Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1937-2017 Class II | Autolube-III with Foot Guard Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1936-2017 Class II | AL-III-DISS Adapter Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1935-2017 Class II | Autolube-III with 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1934-2017 Class II | Autolube-III Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1933-2017 Class II | Foot control irrigation system Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1932-2017 Class II | AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1931-2017 Class II | AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1930-2017 Class II | 14cm QD Angle Attachment Product Usage: Product attachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-2840-2016 Class II | G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone…The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 08/26/2016Terminated |
| Z-2839-2016 Class II | G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and…The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 08/26/2016Terminated |
| Z-2838-2016 Class II | G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone…The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. | 08/26/2016Terminated |
| Z-2837-2016 Class II | G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and…Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were… | 08/26/2016Terminated |
| Z-2784-2016 Class I | Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light…There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II… | 06/24/2016Terminated |
| Z-2783-2016 Class I | Light Adaptor for Small Battery Drive and Small Battery Drive II.There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II… | 06/24/2016Terminated |
| Z-2253-2016 Class II | Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping…The graphics at the attachment interface indicating locked and unlocked position are reversed. | 06/15/2016Terminated |
| Z-1668-2016 Class II | ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part #…Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and… | 03/28/2016Terminated |
| Z-1667-2016 Class II | ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part #…Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and… | 03/28/2016Terminated |
| Z-1994-2016 Class II | Universal Battery Charger II (UBC II)The device is reported to enter safe mode and is no longer able to charge batteries. | 01/15/2016Terminated |
| Z-2126-2016 Class II | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort…Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead… | 11/25/2015Terminated |
| Z-1246-2016 Class II | Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical…Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). | 11/02/2015Terminated |
| Z-2345-2015 Class II | Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.Saw head separated from the drive unit or began to come loose. | 07/01/2015Terminated |
| Z-2313-2015 Class II | ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2312-2015 Class II | ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2311-2015 Class II | ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2310-2015 Class II | ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2309-2015 Class II | ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2308-2015 Class II | ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2307-2015 Class II | ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2306-2015 Class II | ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2305-2015 Class II | ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2304-2015 Class II | ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1.…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2303-2015 Class II | ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2302-2015 Class II | ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2301-2015 Class II | ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2300-2015 Class II | ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2299-2015 Class II | ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2298-2015 Class II | ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2297-2015 Class II | ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2296-2015 Class II | ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2295-2015 Class II | ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2294-2015 Class II | ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2293-2015 Class II | ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2292-2015 Class II | ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2291-2015 Class II | ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2290-2015 Class II | ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2289-2015 Class II | ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2288-2015 Class II | ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2287-2015 Class II | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2286-2015 Class II | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2285-2015 Class II | ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2284-2015 Class II | ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2283-2015 Class II | ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2282-2015 Class II | ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2281-2015 Class II | ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-2280-2015 Class II | ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone…G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are… | 04/13/2015Terminated |
| Z-1553-2015 Class II | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for…The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece.… | 03/24/2015Terminated |
| Z-1037-2015 Class II | 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping…Customer complaint indicating the color bands on the MIA16-G1 were not correct. | 12/10/2014Terminated |
| Z-1017-2016 Class II | Synthes Small Electric Drive (SED)May operate solely in reverse mode, not operate in reverse mode when intended, not function or an… | 11/14/2014Open, Classified |
| Z-0747-2016 Class II | Synthes Small Electric Drive (SED). For use in general traumatology.The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when… | 08/14/2014Terminated |
| Z-1983-2014 Class II | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone…Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when… | 05/08/2014Terminated |
| Z-1574-2014 Class II | ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG…Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. | 01/08/2014Terminated |
| Z-0729-2014 Class II | Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C…Some carbide cutting burr fractured during use. | 12/17/2013Terminated |
| Z-0728-2014 Class II | Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part #…Some carbide cutting burr fractured during use. | 12/17/2013Terminated |
| Z-0727-2014 Class II | Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L…Some carbide cutting burr fractured during use. | 12/17/2013Terminated |
| Z-0726-2014 Class II | Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part…Some carbide cutting burr fractured during use. | 12/17/2013Terminated |
| Z-1629-2014 Class II | Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying…The Irrigation Clips were assembled with the incorrect (smaller) clips. | 12/03/2013Terminated |
| Z-0779-2014 Class II | Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are…Product did not reach expected sterility assurance level | 05/06/2013Terminated |
| Z-0657-2014 Class II | ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer:…The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill… | 04/25/2013Terminated |
| Z-0656-2014 Class II | ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc.…The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill… | 04/25/2013Terminated |
| Z-0655-2014 Class II | ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended…The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill… | 04/25/2013Terminated |
| Z-0654-2014 Class II | ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc.…The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill… | 04/25/2013Terminated |
| Z-1919-2014 Class II | ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1918-2014 Class II | ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1917-2014 Class II | ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1916-2014 Class II | ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1915-2014 Class II | ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1914-2014 Class II | ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1913-2014 Class II | ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1912-2014 Class II | ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1911-2014 Class II | ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1910-2014 Class II | ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1909-2014 Class II | ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1908-2014 Class II | ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1907-2014 Class II | ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1906-2014 Class II | ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1905-2014 Class II | ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1904-2014 Class II | ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1903-2014 Class II | ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1902-2014 Class II | ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1901-2014 Class II | ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1900-2014 Class II | ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1899-2014 Class II | ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1898-2014 Class II | ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1897-2014 Class II | ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |
| Z-1896-2014 Class II | ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This…The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were… | 11/28/2012Terminated |