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Wrench
FDA product code HXC · Class 1 · Orthopedic
1,216
Registered devices
1,583
Adverse events
8
Recalls
6
510(k) clearances
Devices with this code
DISTRACTION, INTERNAL — KLS-Martin L.P.DISTRACTION, INTERNAL — KLS-Martin L.P.ILIZAROV SYSTEMS — Smith & Nephew, Inc.Flatwrench — I.T.S. GmbHNA — Synthes GmbHNA — Synthes GmbHn/a — MEDTRONIC SOFAMOR DANEK, INC.Anyplus II Spinal Fixation System — GS Medical Co., Ltd.Kalitec Universal Instruments — Kalitec Direct LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Ratcheting Wrench — Biomet Orthopedics, LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.NA — Synthes GmbHKMEDIC — TELEFLEX INCORPORATEDMAESTRO(TM) TOTAL WRIST — Biomet Orthopedics, LLCDyna Locking Trochanteric Nail — CG MedTech Co.,Ltd.Salvo® Spine System — Spine Wave, Inc.n/a — MEDTRONIC SOFAMOR DANEK, INC.Natural-Knee® — Zimmer, Inc.Reform Pedicle Screw System — PRECISION SPINE, INC.TC-PLUS / RT-PLUS — Smith & Nephew, Inc.Placement Wrench for LSB Bolts — Ad-Tech Medical Instrument CorporationSIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC.MAVERICK MINI — Smith & Nephew, Inc.
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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