Home › Device types › KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
FDA product code KWY · Class 2 · Orthopedic
13,142
Registered devices
16,502
Adverse events
88
Recalls
99
510(k) clearances
Devices with this code
Corin Bipolar Prosthesis — CORIN LTDP.C.A. — Howmedica Osteonics Corp.Avenir® — Zimmer GmbHTrident X3 Insert — Howmedica Osteonics Corp.OMNI ARC Hip — Omni Life Science, Inc.M2A MAGNUM HIP SYSTEM — Biomet Orthopedics, LLCArcos® STS™ Modular Revision System — Biomet Orthopedics, LLCMultiPolar® — Zimmer, Inc.Metafix Hip Stem — CORIN LTDResolve Modular Revision Stem — UNITED ORTHOPEDIC CORP.Alloclassic® Zweymüller® SL — Zimmer GmbHC-Taper Head — Howmedica Osteonics Corp.Centrax — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Dynasty — Microport Orthopedics Inc.CORAIL — DEPUY (IRELAND)INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.EMPHASYS — DEPUY (IRELAND)Avenir® Müller — Zimmer GmbHFitmore® — Zimmer GmbHExeter — Howmedica Osteonics Corp.Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.NA — Exactech, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Total Joint Orthopedics, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infectio |
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infectio |
| 2024-10-15 | Smith & Nephew, Inc. | The Bipolar assembly contains an oversized Retainer Ring. |
| 2024-04-26 | Exactech, Inc. | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and Augus |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| 2020-02-26 | Biomet, Inc. | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
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