Depuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk
DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
What this means for you
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: This is an FDA Class II recall involving a surgical implant where sterility has been potentially compromised. Although no adverse health consequences are reported in the source text, the risk of post-surgical infection from a non-sterile implant presents a direct risk of harm to patients receiving the device.
Plain-English summary
Depuy Synthes is recalling the ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM (Part Number 150450207, Lot Number 1007046) distributed nationwide in Minnesota, North Carolina, and Texas. The external sterile packaging was found adhered to the internal sterile packaging, which could potentially compromise the sterility of the device.
Physicians and medical institutions that received this lot should stop using the affected units and contact Depuy Synthes or their medical device representative for further instructions regarding return or replacement.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
- Manufacturer
- DEPUY (IRELAND)
- Hazard
- sterility-compromise
- surgical-infection-risk
Distribution
Distributed nationwide across the United States.
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