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Klassic Knee Tibial Insert, CR/Congruent, Size 2, 14 mm, Final Packed, Sterile

TOTAL JOINT ORTHOPEDICS, INC. · Model 5300.02.014 · UDI-DI 00814703010804

JWH Prescription
1
510(k) clearances
157,469
Adverse events (262 deaths)
983
Recalls
315
Facilities

Recalls

DateFirmReason
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 have a packaging discr
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)
2025-06-02Encore Medical, LPDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu
2025-06-02Encore Medical, LPDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.