Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text explicitly states a packaging defect that "potentially" compromises sterility, but no illnesses or injuries are reported. The hazard is theoretical rather than demonstrated.
Plain-English summary
Depuy Synthes is recalling ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM (Part Number: 150450105) distributed nationwide in Minnesota, North Carolina, and Texas. The external sterile packaging was found adhered to the internal sterile packaging, which could compromise the sterility of the device.
Affected units include Lot Number AF1007829 (expiration date: 12/31/2035). This is a Class II medical device recall.
If you have received this product, contact Depuy Synthes or the FDA for further guidance. Do not use the affected device without consulting with the manufacturer or a healthcare provider.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
- Manufacturer
- DEPUY (IRELAND)
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27