DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving potential sterility compromise of an implantable orthopedic component. No reported illnesses or injuries are stated in the source, but compromised sterility of a surgical implant represents a direct risk of serious harm (infection, revision surgery).
Plain-English summary
DePuy (Ireland) is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM (part number 150450107, UDI-DI: 10603295533139, lot number 1006440) nationwide in Minnesota, North Carolina, and Texas. The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising the sterility of the device.
Patients who received this product should contact their healthcare provider for guidance on next steps. Healthcare providers should review patient medical records to identify affected recipients.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
- Manufacturer
- DEPUY (IRELAND)
- Hazard
- sterility-compromise
- contamination
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