Instrument, Manual, Surgical, General Use
FDA product code MDM · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
44510(k) clearances
0PMA approvals
38recalls
Manufacturers
- Savoy Medical Supply Co., Inc. 4
- Falcon Instruments, Inc. 3
- Acuderm, Inc. 2
- DeRoyal Industries Inc 2
- Cypress Medical Products, Ltd. 1
- Injectimed, Inc. 1
- Surgical Safety Products, Inc. 1
- Bip USA, Inc. 1
- O.R. Concepts, Inc. 1
- American Biomaterials Corp. 1
- American Safety Razor Co. 1
- Tri-State Hospital Supply Corporation 1
- Dermtec, Inc. 1
- The Anspach Effort, Inc. 1
- Fray Products Corp. 1
- Supra Instruments, Inc. 1
- Murphy Medical Center 1
- Jain Surgical Equipment, Inc. 1
- Medovations, Inc. 1
- Dynarex Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073664 | Frontline Medical Safetynet Guidewire IntroducerMDM · Traditional | Injectimed, Inc. | 08/08/2008SE |
| K050575 | Futumeds No Patient Contact Safety Lancet with Pals SystemMDM · Traditional | Futumeds Sdn Bhd | 08/15/2005SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
| K022059 | Microvasive Pulmonary GuidewireMDM · Traditional | Boston Scientific Corp | 11/13/2002SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | Minrad, Inc. | 12/07/2001SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K990062 | SaphliftMDM · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 03/30/1999SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
| K945430 | Dermavblade(Tm)MDM · Traditional | Hasting'S Biomedical Corp. | 11/28/1994SE |
| K941193 | East West InstrumentsMDM · Traditional | East West Instruments, Inc. | 11/09/1994SE |
| K941907 | Apex Disposable InstrumentsMDM · Traditional | Apex Ent., Inc. | 08/26/1994SE |
| K942818 | Deep SutureMDM · Traditional | Automated Medical Products Corp. | 08/25/1994SE |
| K942896 | Clamps and ClipsMDM · Traditional | Surgin Surgical Instrumentation, Inc. | 07/19/1994SE |
| K940684 | Surgical Instrument, DisposableMDM · Traditional | Her-Mar, Inc. | 03/14/1994SE |
| K933265 | Acu-Dispo-Ce(Tm)MDM · Traditional | Acuderm, Inc. | 03/07/1994SE |
| K933866 | Acu-Hemostatic RingMDM · Traditional | Acuderm, Inc. | 12/01/1993SE |
| K925653 | Dermapunch Disposable Skin Biopsy PunchMDM · Traditional | Dermatopathology Laboratory | 11/08/1993SE |
| K922130 | Hospital Kit DK 117MDM · Traditional | Savoy Medical Supply Co., Inc. | 05/24/1993SEKD |
| K926126 | SuturemateMDM · Traditional | Surgical Safety Products, Inc. | 05/19/1993SE |
| K930775 | Disposable Forceps, Hemostats, Needle Guides, EtcMDM · Traditional | Falcon Instruments, Inc. | 04/23/1993SE |
| K922127 | Hospital Kit GP 103MDM · Traditional | Savoy Medical Supply Co., Inc. | 03/29/1993SESD |
| K923281 | SV 100200 - Single Use Only - Sterile Hospital KitMDM · Traditional | Savoy Medical Supply Co., Inc. | 03/26/1993SE |
| K922128 | Hospital Kit Ep 104MDM · Traditional | Savoy Medical Supply Co., Inc. | 03/23/1993SESK |
| K925874 | Breast StabilizerMDM · Traditional | Bip USA, Inc. | 03/16/1993SE |
| K930399 | Orc Endoscopic Instrument HolderMDM · Traditional | O.R. Concepts, Inc. | 02/17/1993SE |
| K924725 | American Biomed, Inc. Microsurgical InstrumentsMDM · Traditional | American Biomaterials Corp. | 02/05/1993SE |
| K924503 | Personna Safety ScalpelMDM · Traditional | American Safety Razor Co. | 02/05/1993SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | Tri-State Hospital Supply Corp. | 12/17/1992SE |
| K921022 | Disposable CuretteMDM · Traditional | Dermtec, Inc. | 12/03/1992SE |
| K921988 | Laceration Repair TrayMDM · Traditional | Cypress Medical Products, Ltd. | 11/19/1992SEKD |
| K921822 | Fray Bio-PunchMDM · Traditional | Fray Products Corp. | 10/28/1992SE |
| K922874 | Dispsable Forceps, Hemostats, Probes, Needle GuideMDM · Traditional | Supra Instruments, Inc. | 09/11/1992SE |
| K920297 | Disposable ScissorsMDM · Traditional | Falcon Instruments, Inc. | 09/11/1992SE |
| K920296 | Disposable ForcepsMDM · Traditional | Falcon Instruments, Inc. | 09/11/1992SE |
| K921210 | Surgical Instrument StandMDM · Traditional | Murphy Medical Center | 04/29/1992SE |
| K911369 | Qualtex Light Handle and Light Handle CoverMDM · Traditional | Deroyal Industries, Inc. | 05/13/1991SE |
| K911895 | Qualtex Suture BootiesMDM · Traditional | Deroyal Industries, Inc. | 05/08/1991SE |
| K905105 | Jain Suture/Vesiband OrganizerMDM · Traditional | Jain Surgical Equipment, Inc. | 01/31/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | Medovations, Inc. | 12/19/1990SE |
| K855132 | Shave Prep TrayMDM · Traditional | Dynarex Corp. | 01/24/1986SE |
| K812691 | Silicone ImplantsMDM · Traditional | Sutter Biomedical, Inc. | 11/16/1981SE |
| K801328 | The EqualizerMDM · Traditional | The Anspach Effort, Inc. | 06/09/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1605-2025 Class II | Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-0942-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1446-2024 Class II | Centurion STERILE #16 RUBBER BAND, Product Code EB16Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1460-2024 Class II | Trumpet, Needle Guide, Cat# TMS-200The Ring on the Trump Needle Guide can detach when excessive pressure is applied. | Technicality Inc. | 01/31/2024Open, Classified |
| Z-1389-2024 Class II | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit…Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Applied Medical Resources Corp | 01/30/2024Open, Classified |
| Z-1388-2024 Class II | Epix Universal Clip Applier, REF: CA500, STERILEEOTheir is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Applied Medical Resources Corp | 01/30/2024Open, Classified |
| Z-1082-2023 Class II | Sterile Procedural Trays, labeled as the following: IM NAILSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-0774-2023 Class II | 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part…No expiration dates printed on the packaging | ENDO Pharmaceuticals Solutions, Inc. | 11/08/2022Open, Classified |
| Z-0465-2023 Class II | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S…The devices may be packaged with the wrong reamer size. | Arthrex, Inc. | 11/02/2022Open, Classified |
| Z-0531-2022 Class II | 8mm FlexDex Needle Driver, Product Code FD-335 NDThe firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of… | FlexDex Inc. | 12/22/2021Terminated |
| Z-2339-2018 Class II | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non SterileFirm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a… | Trilliant Surgical Ltd. | 03/27/2018Terminated |
| Z-2338-2018 Class II | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non SterileFirm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a… | Trilliant Surgical Ltd. | 03/27/2018Terminated |
| Z-0566-2018 Class II | Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx onlyMedtronic has discovered the product lot in question was noted as having a longer drill tip extension than… | Medtronic Sofamor Danek USA Inc | 12/22/2017Terminated |
| Z-0406-2018 Class II | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.The expiration date provided on the label is incorrect. | Smith & Nephew, Inc. | 10/23/2017Terminated |
| Z-3018-2017 Class II | Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee…The Truliant Tibial Trial Handle's pin may disassociate from the main body. | Exactech, Inc. | 06/23/2017Terminated |
| Z-0061-2015 Class II | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The…The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. | DePuy Orthopaedics, Inc. | 08/27/2014Terminated |
| Z-1932-2013 Class II | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are…During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. | SpineFrontier, Inc. | 08/29/2012Terminated |
| Z-2746-2011 | Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1…The towel clamps packaged with the wire caddy have been found to have blood stains on them which could… | Stryker Instruments Division of Stryker… | 05/27/2011Terminated |
| Z-2176-2012 Class II | Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a…Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the… | Stryker Spine | 03/21/2011Terminated |
| Z-2232-2010 | Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581.…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | Biomet, Inc. | 06/18/2010Terminated |
| Z-2231-2010 | Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile.…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | Biomet, Inc. | 06/18/2010Terminated |
| Z-2230-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | Biomet, Inc. | 06/18/2010Terminated |
| Z-2229-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | Biomet, Inc. | 06/18/2010Terminated |
| Z-2228-2010 | SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports…The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable… | Biomet, Inc. | 06/18/2010Terminated |
| Z-1968-2010 | Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1967-2010 | Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1966-2010 | Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1965-2010 | Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1964-2010 | Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1963-2010 | Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1962-2010 | Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1961-2010 | Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1960-2010 | Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1959-2010 | Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1958-2010 | Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-1957-2010 | Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | Stryker Spine | 05/13/2010Terminated |
| Z-0524-2010 | Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KITPotential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0936-2009 | Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800 Manufactured…DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and… | Stryker Spine | 09/08/2006Terminated |