Driver, Prosthesis
FDA product code HWR · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
4510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K915776 | Knee Prosthesis DriverHWR · Traditional | Kim-Med, Inc. | 06/11/1992SE |
| K875054 | Acromed Ads Bone Nail DriverHWR · Traditional | Buckman Co., Inc. | 01/28/1988SE |
| K870848 | Schultz Metacarpal Component DriverHWR · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
| K870847 | Schultz Phalangeal Component DriverHWR · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1155-2017 Class II | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage:…Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments… | Biomet U.K., Ltd. | 01/05/2016Terminated |
| Z-1154-2017 Class II | Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use…Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments… | Biomet U.K., Ltd. | 01/05/2016Terminated |
| Z-0699-2016 Class II | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws.…Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw… | Smith & Nephew, Inc., Endoscopy Div. | 04/04/2013Terminated |
| Z-1319-2010 | BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS…The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction… | Biomet Microfixation, Inc. | 01/15/2010Terminated |
| Z-0291-2008 | Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat #…The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient. | Pioneer Surgical Technology | 10/10/2007Terminated |
| Z-0290-2008 | Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright…Breakage: breaking of the connecting foot that is on the distal surface of the instrument | Wright Medical Technology Inc | 10/04/2007Terminated |