Home › Device types › HWR
Driver, Prosthesis
FDA product code HWR · Class 1 · Orthopedic
1,552
Registered devices
9,682
Adverse events
6
Recalls
4
510(k) clearances
Devices with this code
VIPER — Medos International SàrlACUMED — Acumed LLCNA — DEPUY SPINE, LLCENDURANCE — DEPUY ORTHOPAEDICS, INC.NA — DEPUY SPINE, LLCLAG SCREW DRIVER — Biomet Orthopedics, LLCU2 Total Knee System — UNITED ORTHOPEDIC CORP.ORTHOLOC™ 3DI — WRIGHT MEDICAL TECHNOLOGY, INC.ENDOSKELETON® TL — MEDTRONIC SOFAMOR DANEK, INC.ACE — ACE SURGICAL SUPPLY CO., INC.F.A.S.T. PEG DRIVER WITH AO — Biomet Orthopedics, LLCEXPEDIUM — Medos International SàrlStelKast Generic Hip instruments — GLOBUS MEDICAL, INC.VIPER — DEPUY SPINE, LLCOffset Femoral Head Impactor Tip — Zimmer, Inc.InTess Lumbar Cage — Kalitec Direct LLCEXPEDIUM VERSE — Medos International SàrlNA — DEPUY SPINE, LLCNA — DEPUY SPINE, LLCADVANCE® — Microport Orthopedics Inc.S-ROM — DEPUY ORTHOPAEDICS, INC.BENGAL — DEPUY SPINE, LLCInvictus — ALPHATEC SPINE, INC.PIPELINE — DEPUY SPINE, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-01-05 | Biomet U.K., Ltd. | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw materi |
| 2016-01-05 | Biomet U.K., Ltd. | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw materi |
| 2013-04-04 | Smith & Nephew, Inc., Endoscopy Div. | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. |
| 2010-01-15 | Biomet Microfixation, Inc. | The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does no |
| 2007-10-10 | Pioneer Surgical Technology | The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient. |
| 2007-10-04 | Wright Medical Technology Inc | Breakage: breaking of the connecting foot that is on the distal surface of the instrument |
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