DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging 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 with no reported injuries or illnesses. The hazard is a packaging defect that potentially compromises sterility—a concern for device integrity but classified by FDA as Class II, which under the rubric corresponds to moderate severity when no adverse outcomes have been reported.
Plain-English summary
DePuy (Ireland) is recalling 3 units of the ATTUNE Revision Hinge Femoral RT SZ 8 CEM (Part Number 150450208) due to a packaging defect. The external sterile packaging was found adhered to the internal sterile packaging, which potentially compromises the sterility of the device.
This product was distributed in the United States in the states of Minnesota, North Carolina, and Texas. Lot numbers AF1008441 and AF1008028 are affected, with an expiration date of 12/31/2035.
Patients who have received or may receive this device should contact their healthcare provider or DePuy if they have any concerns about the sterility of the device or if they experience any signs of infection.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
- Manufacturer
- DEPUY (IRELAND)
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441
- AF1008028. Expiration Date: 12/31/2035.
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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