ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.
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: Labeling errors on medical device components create risk of patient harm through compromised product identification and traceability. No illnesses or injuries have been reported, supporting a High rather than Severe rating.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 5 units of ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6, a component of the ATTUNE Total Knee Replacement System. The product is identified by Model No. 150621006, UDI-DI 10603295507451, and Lot JA06A0252.
The product has been determined to be incorrectly labeled.
The recalled product was distributed nationwide in the United States in California, Illinois, New Jersey, and Wisconsin, as well as in Canada.
The recalled product
- Product
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 5
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 (3)
- Model No: 150621006
- UDI-DI: 10603295507451
- Lot JA06A0252.
Distribution
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