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.
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. 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)
- 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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