Home › Device types › KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
FDA product code KWL · Class 2 · Orthopedic
6,625
Registered devices
2,683
Adverse events
50
Recalls
108
510(k) clearances
Devices with this code
Optimom Modular Heads — CORIN LTDP.C.A. — Howmedica Osteonics Corp.Avenir® — Zimmer GmbHTrident X3 Insert — Howmedica Osteonics Corp.B-P TOTAL HIP SYSTEM — ENDOTEC, INC.Metafix Hip Stem — CORIN LTDMANZA HEADS — STINSON ORTHOPEDICS INC.Alloclassic® Zweymüller® SL — Zimmer GmbHINSTRUMENT — Howmedica Osteonics Corp.CORAIL — DEPUY (IRELAND)INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.EMPHASYS — DEPUY (IRELAND)Fitmore® — Zimmer GmbHConserve — Microport Orthopedics Inc.ARCOS ONE-PIECE REVISION SYSTEM — Biomet Orthopedics, LLCRestoration — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.P.C.A. — Howmedica Osteonics Corp."UNITED" USTAR II Knee System — UNITED ORTHOPEDIC CORP.Orthinox — Howmedica Osteonics Corp.Restoration — Howmedica Osteonics Corp.UHR — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product m |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product m |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product m |
| 2018-06-21 | DePuy Orthopaedics, Inc. | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loo |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), conta |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), conta |
| 2015-11-16 | Smith & Nephew, Inc. | The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing i |
| 2009-06-26 | Stryker Howmedica Osteonics Corp. | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallu |
| 2009-01-06 | Stryker Howmedica Osteonics Corp. | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| 2007-10-26 | Stryker Howmedica Osteonics Corp. | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. |
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