FDADecember 7, 2021device
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
What to do
FDA enforcement status: Terminated
Brands named
depuy orthopaedicsdepuy
UPCs
10603295004097
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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