Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Reported: November 8, 2023 Initiated: October 13, 2023 #Z-0214-2024
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.
Details
- Recalling Firm
- Corin Ltd
- Units Affected
- 1 units
- Distribution
- US: MI, TX, IL
- Location
- Cirencester, N/A
Frequently Asked Questions
What product was recalled? ▼
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty. Recalled by Corin Ltd. Units affected: 1 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0214-2024.
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