FDAFebruary 22, 2021device
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethy...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
What to do
FDA enforcement status: Terminated
Brands named
depuy orthopaedicsdepuy
UPCs
10603295492054106032954920611060329549207810603295492085106032954920921060329549210810603295492115
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.2026-04-03
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