DePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall
DePuy Synthes is recalling ATTUNE Revision Hinge Knee Insert Components distributed to Minnesota, North Carolina, and Texas 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 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: This is an FDA Class II recall of a sterile medical device with a packaging defect that potentially compromises sterility—a risk-of-harm scenario for implanted surgical components. No illnesses or injuries are reported in the source, but sterility compromise in an orthopedic implant poses significant potential for infection risk.
Plain-English summary
DePuy Synthes is recalling certain ATTUNE Knee System Revision Hinge Insert components 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 product.
A total of 160 units were distributed to medical facilities in Minnesota, North Carolina, and Texas. The recalled components include 40 different part numbers ranging from 8mm to 26mm sizes, with specific lot numbers identified for each part.
Healthcare providers and patients who have received these components should contact DePuy Synthes or consult with their healthcare provider regarding the recall. Patients should not attempt to remove or replace the device without medical guidance.
The recalled product
- Product
- Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number…
- Manufacturer
- DEPUY (IRELAND)
- Affected units
- 160
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · DEPUY (IRELAND)
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