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Broach
FDA product code HTQ · Class 1 · Orthopedic
2,067
Registered devices
4,734
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
iNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLCNEUFLEX — DEPUY ORTHOPAEDICS, INC.Femoral Broach — TOTAL JOINT ORTHOPEDICS, INC.Polar — Smith & Nephew, Inc.Calix Spinal Implant System — Xtant Medical Holdings, Inc.Anthology — Smith & Nephew, Inc.Tornier Latitude — TORNIER, INC.General Instrument — ALPHATEC SPINE, INC.MIB Broach — Trilliant Surgical, LLCMDI — WRIGHT MEDICAL TECHNOLOGY, INC.OrthoMedFlex — ORTHOMEDFLEX LLCNA — DEPUY (IRELAND)SILICONE MCP — Stryker GmbHPremier-Total™ — Zimmer, Inc.BioMotion® Cannulated 1st MPJ Hemi System — Ascension Orthopedics, Inc.Ascension® — Ascension Orthopedics, Inc.S-ROM — DEPUY ORTHOPAEDICS, INC.DJO SURGICAL — Encore Medical, L.P.EXACT/ALLIANCE — Biomet Orthopedics, LLCIntervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC.iNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLCSILICONE PIP — Stryker GmbHDJO SURGICAL — DJO, LLCiNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-23 | Greatbatch Medical | Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical |
| 2011-04-21 | Encore Medical, Lp | Strike plate may dislodge from the broach stem handle during impaction of the device. |
| 2009-04-29 | Zimmer Inc. | The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded t |
| 2009-03-13 | Zimmer Inc. | The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions. |
| 2008-01-25 | Stryker Howmedica Osteonics Corp. | Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture. |
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