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Wrench
FDA product code HXC · Class 1 · Orthopedic
1,199
Registered devices
1,571
Adverse events
8
Recalls
6
510(k) clearances
Devices with this code
Jenitek Torque Wrench — SUZHOU JENITEK MEDICAL CO.,LTD.PINNACLE GRIPTION TF — DEPUY (IRELAND)XtraFix® — Zimmer, Inc.PINNACLE — DEPUY ORTHOPAEDICS, INC.Excella® — INNO Holdings, Inc.NA — Zimmer, Inc.Encore Revision Kit — Siesta MedicalChoice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™) — Choice Spine, LPHELMUT ZEPF — Helmut Zepf Medizintechnik GmbHSALVATION — WRIGHT MEDICAL TECHNOLOGY, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Dynex — VILEX LLCKarl Schumacher — Karl Schumacher Dental, LLCNA — Synthes GmbHNA — Synthes GmbHPINNACLE GRIPTION TF — DEPUY (IRELAND)X FIX — Biomet Orthopedics, LLCN/A — WRIGHT MEDICAL TECHNOLOGY, INC.X FIX — Biomet Orthopedics, LLCHELMUT ZEPF — Helmut Zepf Medizintechnik GmbHTrigen — Smith & Nephew, Inc.Trauma-Ex-Fix — Smith & Nephew, Inc.Battalion — ALPHATEC SPINE, INC.SFS — Orthofix US LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-08-14 | New Standard Device Inc | Due to manufacturing processing error, wrench causing stripping when torqueing nuts. |
| 2016-01-08 | Orthofix, Inc | There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected dro |
| 2015-07-07 | Aesculap, Inc. | A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not i |
| 2015-03-12 | Biomet Spine, LLC | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for |
| 2015-03-12 | Biomet Spine, LLC | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for |
| 2015-02-02 | Bradshaw Medical Inc. | A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. |
| 2012-07-24 | DePuy Spine, Inc. | A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outsi |
| 2008-11-07 | Zimmer Inc. | Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical tech |
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