Motor, Surgical Instrument, Pneumatic Powered
FDA product code GET · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
23510(k) clearances
0PMA approvals
52recalls
Manufacturers
- Midas Rex Pneumatic Tools, Inc. 5
- Amsco Co. 4
- Surgical Dynamics, Inc. 2
- United States Surgical, A Division of Tyco Healthc 2
- American Safety 1
- Surgical Mechanical Research, Inc. 1
- Micro-Aire Surgical Instruments, Inc. 1
- Suncoast Medical Manufacturers, Inc. 1
- Eder Instrument Co, Inc. 1
- Stryker Corporation 1
- American Silk Sutures, Inc. 1
- Sen Tech Medical Corp. 1
- Sodem Diffusion SA 1
- Aesculap, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960473 | Aesculap Power System HandpieceGET · Traditional | Aesculap, Inc. | 03/07/1996SE |
| K955174 | Sodem High Speed System for Neurosurgery & Median StyernotomyGET · Traditional | Sodem Diffusion SA | 01/22/1996SE |
| K942987 | Nucleotome L KitGET · Traditional | Surgical Dynamics, Inc. | 10/30/1995SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 09/15/1995SE |
| K953432 | Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 09/14/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | Midas Rex Pneumatic Tools, Inc. | 05/26/1995SE |
| K914753 | Auto Suture(R) Articulating Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 06/11/1992SE |
| K910071 | Porta Gas Compressed Gas Cylinder CartGET · Traditional | Sen Tech Medical Corp. | 03/22/1991SE |
| K904578 | Modification Auto Suture(R) Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 10/30/1990SE |
| K885066 | Hematome SystemGET · Traditional | Surgical Dynamics, Inc. | 05/01/1989SE |
| K872951 | American Brain Retractor CoverGET · Traditional | American Silk Sutures, Inc. | 09/16/1987SE |
| K863447 | Stryker Orthopower 90 & Orthopower 90 System IIGET · Traditional | Stryker Corp. | 09/29/1986SE |
| K843498 | Bipolar Suction ElectrodeGET · Traditional | Eder Instrument Co, Inc. | 12/14/1984SE |
| K840370 | Surg-A-Stat Vasectomy TipGET · Traditional | Suncoast Medical Manufacturers, Inc. | 07/23/1984SE |
| K833187 | Hall OsteonGET · Traditional | Amsco Co. | 10/31/1983SE |
| K832188 | Hall ReciprocatorGET · Traditional | Amsco Co. | 08/12/1983SE |
| K832187 | Hall OscillatorGET · Traditional | Amsco Co. | 08/12/1983SE |
| K832186 | Hall Drill/ReamerGET · Traditional | Amsco Co. | 08/12/1983SE |
| K831675 | Twist Lock Drill 1120GET · Traditional | Micro-Aire Surgical Instruments, Inc. | 06/30/1983SE |
| K800382 | Clear-View Mirror WarmerGET · Traditional | Surgical Mechanical Research, Inc. | 05/14/1980SE |
| K790195 | Foot ValveGET · Traditional | American Safety | 02/26/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1391-2023 Class II | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used…Incorrect Unique Device Identifier/GTIN code was used on product. | Pro-Dex Inc | 02/14/2023Open, Classified |
| Z-1957-2017 Class II | System Console, Single Port, no irrigationSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 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. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1834-2016 Class II | Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use…MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to… | MicroAire Surgical Instruments, LLC | 03/11/2016Terminated |
| Z-0623-2014 Class II | Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and…Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure… | Aesculap, Inc. | 12/09/2013Terminated |
| Z-0406-2009 | ConMed Linvatec Hall Surgical Blades, Sterile THIN X-FINE, Catalog # L135 ConMed…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0405-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE REPL BLD/STRYKER, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0404-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE ACL BLD, Catalog # 00502318200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0403-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER RPLCMNT BLADE/STRYKER RECIP, Catalog…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0402-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER REPT STERNTMY BLD, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0401-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER OSC BLD, Catalog # 00507118000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0400-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0399-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAGITTAL BLD FINE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0398-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG/OSC BLADE, Catalog # 00505928200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0397-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0396-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLDE CRS, Catalog # 00502313300…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0395-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLD FN 70D, Catalog # 00502312900…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0394-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL STRYKER SAG, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0393-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0392-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/SARNS STERNUM SAW, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0391-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPEAT STERN BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0390-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST RECIPROCATOR BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0389-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0388-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD, Catalog # 00507157200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0387-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLADE, ME-92 COAT, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0386-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE, Catalog # 00507155200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0385-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE RADSD, Catalog # 00502316500…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0384-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE FINE, Catalog # 00502316100…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0383-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC ABRASION BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0382-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLD, Catalog # 00507114500…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0381-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO RECIP SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0380-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO OSCILLSAW BLADE, ANG, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0379-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST EXTENDED STERNUM SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0378-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN, Catalog #00507120100…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0377-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST ACL BLADE, Catalog # 00502318500 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0376-2009 | ConMed Linvatec Hall Surgical Blades, Sterile Catalog ADVANCED CUT SAG SAW BLD, Catalog…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0375-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE THIN, Catalog # K132…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0374-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE, Catalog # K121, K141…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0373-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAG BLADE Bent or Angled, Catalog # U335…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0372-2009 | ConMed Linvatec Hall Surgical Blades, Sterile REPEAT STERNOTOMY BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0371-2009 | ConMed Linvatec Hall Surgical Blades, Sterile RECIPROCATOR BLADE, Catalog # 00505226000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0370-2009 | ConMed Linvatec Hall Surgical Blades, Sterile RECIP SAW BLADE, Catalog # U773 and P513…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0369-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSCILLATING KNEE BLADE, Catalog # L192 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0368-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSCBLD, Catalog # 00507158900 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0367-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSC SAW BLAD, Catalog # L121, L122, L145…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0366-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0365-2009 | ConMed Linvatec Hall Surgical Blades, Sterile MICRO SAG SAW BLADE FINE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0364-2009 | ConMed Linvatec Hall Surgical Blades, Sterile MAX DRV OSC BLD, Catalog # 00507318100.…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0363-2009 | ConMed Linvatec Hall Surgical Blades, Sterile LG BONE OSC BLADE, Catalog #00507154800…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |
| Z-0362-2009 | ConMed Linvatec Hall Surgical Blades, Sterile INTEX BLADE, Catalog # 00507132000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | Linvatec Corp. | 02/21/2008Terminated |