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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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)
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 9 recalled by DEPUY (IRELAND) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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