Z-0214-2024 Class II Ongoing
FDA device recall Z-0214-2024 was initiated by Corin Ltd on October 13, 2023 and is designated Class II. Reason for recall: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. The recall status is ongoing. Affected quantity: 1 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- October 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Reason for Recall
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Distribution Pattern
US: MI, TX, IL
Code Information
UDI/DI 05055343872505, Lot Number 532405.