DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal 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 with no reported illnesses or injuries. The hazard is sterility compromise from packaging defect, which is a precautionary concern rather than a confirmed harm event. Class II recalls without adverse event reports typically score 2 per the rubric.
Plain-English summary
DePuy Synthes is recalling the ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM (Part Number: 150450108) due to a manufacturing issue identified during quality control. The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising the sterility of the device.
A total of 3 units were distributed nationwide in Minnesota, North Carolina, and Texas. The affected lot is AF1006441, with expiration date 12/31/2035 (UDI-DI: 10603295543022).
Patients or healthcare providers who have this device should contact DePuy Synthes for instructions on replacement or return. Use of a device with compromised sterility poses a potential risk of infection at the surgical site.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
- Manufacturer
- DEPUY (IRELAND)
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
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