Z-1456-2024 Class II Ongoing
FDA device recall Z-1456-2024 was initiated by DePuy Orthopaedics, Inc. on March 12, 2024 and is designated Class II. Reason for recall: Product incorrectly labelled. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- March 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Reason for Recall
Product incorrectly labelled.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Code Information
Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.