Home › Device types › HWR
Driver, Prosthesis
FDA product code HWR · Class 1 · Orthopedic
1,572
Registered devices
9,892
Adverse events
6
Recalls
4
510(k) clearances
Devices with this code
U2™ Hip — UNITED ORTHOPEDIC CORP.Maira Anterior Cervical System — Kalitec Direct LLCEXPEDIUM — Medos International SàrlEVOLUTION® — Microport Orthopedics Inc.EAGLE — DEPUY SPINE, LLCSQUARE DRIVER — Biomet Orthopedics, LLCNA — DEPUY SPINE, LLC45MM BRIDGEBACK RMR — Zimmer, Inc.ACE — ACE SURGICAL SUPPLY CO., INC.CONCORDE — DEPUY SPINE, LLCStelKast Generic Hip instruments — GLOBUS MEDICAL, INC.COUGAR — DEPUY SPINE, LLCNA — DEPUY SPINE, LLCMOSS — DEPUY SPINE, LLCNA — Smith & Nephew, Inc.SKYLINE — DEPUY SPINE, LLCCannulated Dilator — Biomet Orthopedics, LLCCETRA — Orthofix US LLCStreamline TL Spinal Fixation System — Pioneer Surgical Technology, Inc.Trigen — Smith & Nephew, Inc.SALVATION — WRIGHT MEDICAL TECHNOLOGY, INC.SkyOPS — Sky Surgical, LLC62MM BRIDGEBACK RMR — Zimmer, Inc.NA — DEPUY INTERNATIONAL LTD
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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