DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found 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 3/5 (High).
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: The FDA classified this as Class II. The hazard involves potential loss of sterility on a surgical implant—a risk-of-harm product where injury has not been reported. No illnesses or injuries are stated in the source, but compromised sterility on an implant poses a theoretical but significant health risk, meeting the High criteria.
Plain-English summary
DePuy Synthes (Ireland) is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM (Part Number 150450204) due to a packaging defect. The external sterile packaging was found adhered to the internal sterile packaging, which could potentially compromise the sterility of the device.
The affected units were distributed nationwide in Minnesota, North Carolina, and Texas. The lot number is 1005229 with an expiration date of 10/31/2035 (UDI-DI: 10603295533153).
Anyone who has received this product should contact their healthcare provider or DePuy Synthes immediately. Healthcare facilities should quarantine affected units and not use them.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
- 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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