Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 23 recalls
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Due to packaging discrepancy with incorrect product size mixed up.
Due to packaging discrepancy with incorrect product size mixed up.
Knee and Humeral socket implants contain incorrect labeling.
942-01-40G 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 discrepancy, which may cause surgical delay t…
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Knee implants contain incorrect labeling (size and/or side incorrect)
Knee implants contain incorrect labeling (size and/or side incorrect)
Due 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 result in a revision surgery if used.
Due 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 result in a revision surgery if used.
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.