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.
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 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)
- 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
Same manufacturer · DEPUY (IRELAND)
See all →- HighDePuy Synthes ATTUNE Revision Hinge Knee Components Packaging Sterility Issue
FDA (Devices) · 2026-07-08
- HighDePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall
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- HighDePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
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- ModerateDePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
FDA (Devices) · 2026-05-06
- ModerateDePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
FDA (Devices) · 2026-05-06
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