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Broach
FDA product code HTQ · Class 1 · Orthopedic
2,067
Registered devices
4,622
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
ATTUNE — DEPUY (IRELAND)Allure Hip Stem — WALDEMAR LINK GmbH & Co. KGUniSyn Hip System — Shalby Advanced Technologies, Inc.PROstep™ TBC — WRIGHT MEDICAL TECHNOLOGY, INC.DJO SURGICAL — Encore Medical, L.P.Anthology — Smith & Nephew, Inc.Anthology — Smith & Nephew, Inc.General Instruments — ALPHATEC SPINE, INC.OSS™ — Biomet Orthopedics, LLCC-STEM — DEPUY INTERNATIONAL LTDIntervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC.OrthoMedFlex — ORTHOMEDFLEX LLCAnthology — Smith & Nephew, Inc.SILICONE MCP — Stryker GmbHMICRONAIL — WRIGHT MEDICAL TECHNOLOGY, INC.EcoFit® broach 133° — implantcast GmbHSILICONE PIP — Stryker GmbHAlteon — Exactech, Inc.Klassic HD Modular Femoral Broach — TOTAL JOINT ORTHOPEDICS, INC.Alliance® — Biomet Orthopedics, LLCAscension MCP Joint Replacement — Smith & Nephew, Inc.PLIF — DEPUY SPINE, LLCPolar — Smith & Nephew, Inc.CATALYSTEM — Smith & Nephew, Inc.
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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