Z-0524-2024 Class II Ongoing
FDA device recall Z-0524-2024 was initiated by Limacorporate S.p.A on October 27, 2023 and is designated Class II. Reason for recall: Due to incorrect product labeling The recall status is ongoing. Affected quantity: 33 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 devices
Product Description
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Reason for Recall
Due to incorrect product labeling
Distribution Pattern
U.S Distribution: AZ, CA, IL, LA, and NY
Code Information
Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167