FDA Device Intelligence
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Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA product code JWH · Class 2 · Orthopedic

85,143
Registered devices
158,735
Adverse events
985
Recalls
921
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-10-02CORIN MEDICAL, LTD.Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be d
2026-07-30Howmedica Osteonics Corp.Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f
2026-05-20United Orthopedic Corp.Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-02-16Encore Medical, LPDue to packaging discrepancy with incorrect product size mixed up.
2026-02-16Encore Medical, LPDue to packaging discrepancy with incorrect product size mixed up.
2026-01-15Encore Medical, LPKnee and Humeral socket implants contain incorrect labeling.
2026-01-05Encore Medical, LP942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also hav
2025-07-31Waldemar Link GmbH & Co. KG (Mfg Site)Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
2025-07-09Encore Medical, LPKnee implants contain incorrect labeling (size and/or side incorrect)
2025-07-09Encore Medical, LPKnee implants contain incorrect labeling (size and/or side incorrect)

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.