FDAFebruary 15, 2023device
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
What to do
FDA enforcement status: Ongoing
Brands named
depuy orthopaedicsdepuy
UPCs
10603295049944
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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