Home › Device types › KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
FDA product code KWY · Class 2 · Orthopedic
13,166
Registered devices
16,531
Adverse events
88
Recalls
99
510(k) clearances
Devices with this code
U-Motion II E-XPE Cup liner, 20 DEG — UNITED ORTHOPEDIC CORP.SL-PLUS/INTEGRATION-PLUS — Smith & Nephew, Inc.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.BENCOX THR System — Corentec Co., LtdINSTRUMENT — Howmedica Osteonics Corp.Fitmore® Hip Stem — Zimmer GmbHSignature BiPolar Head — SIGNATURE ORTHOPAEDICS PTY LTDTANDEM — Smith & Nephew, Inc.REVISION — LIMACORPORATE SPARestoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.OSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCUTF Hip Stem — UNITED ORTHOPEDIC CORP.Metafix Hip Stem — CORIN LTDBENCOX Hip System — Corentec Co., LtdAcumatch L-Series — Exactech, Inc.BENCOX Hip System — Corentec Co., LtdBENCOX Hip System — Corentec Co., LtdConsensus® Hip System — CONSENSUS ORTHOPEDICS, INC.ARCOS ONE-PIECE REVISION SYSTEM — Biomet Orthopedics, LLCX-Change — Howmedica Osteonics Corp.United Hip System, U2 Bipolar Implant — UNITED ORTHOPEDIC CORP.INSTRUMENT — Howmedica Osteonics Corp.
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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