DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was 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 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 source indicates an FDA Class II recall involving a sterility-compromising defect on an implantable orthopedic device. While no reported illnesses or injuries are mentioned in the source, the potential for infection from a compromised sterile implant represents a high-risk condition that merits a High (3) rating under the rubric criterion for risk-of-harm products.
Plain-English summary
DePuy (Ireland) is recalling 3 units of the ATTUNE Revision Hinge Femoral RT Size 3 Cement (Part Number 150450203, Lot 1007537, UDI-DI: 10603295533146) due to a sterility defect.
The external sterile packaging was found adhered to the internal sterile packaging, which could compromise the sterility of the device. This is an FDA Class II recall.
The affected units were distributed nationwide in Minnesota, North Carolina, and Texas. Patients and healthcare providers should stop use and contact DePuy Synthes or consult the FDA website for further guidance on managing affected devices.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
- 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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