DePuy Synthes ATTUNE Revision Hinge Knee Components Packaging Sterility Issue
DePuy Synthes is recalling ATTUNE Revision Hinge Knee Housing Components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility. The recall affects 66 units distributed to Minnesota, North Carolina, and Texas.
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 potential sterility compromise, which presents a risk of adverse health consequences if the compromised sterility allows contamination. The source text does not report any illnesses or injuries, but the hazard (loss of sterility) is substantive and directly threatens patient safety.
Plain-English summary
DePuy Synthes is recalling multiple lots of ATTUNE Revision Hinge Knee Housing Components across 22 different part numbers. The recall was initiated because the external sterile packaging was found adhered to the internal sterile packaging, which could potentially compromise the sterility of the device.
The affected medical device components were distributed to Minnesota, North Carolina, and Texas. A total of 66 units are involved in this recall. The specific part numbers range from 151730010 through 151730052, each with their corresponding lot numbers identified in the FDA recall notice.
Patients who have received these components should contact their healthcare provider or DePuy Synthes directly with any concerns. Healthcare facilities should verify whether they received affected lots and take appropriate action according to the manufacturer's instructions.
The recalled product
- Product
- Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND…
- Manufacturer
- DEPUY (IRELAND)
- Affected units
- 66
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AF1007333
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
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