Unity Total Knee System recall
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Why was Unity Total Knee System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05055343872505, Lot Number 532405.
- Product
- Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Recalling firm
- Corin Ltd
- Quantity
- 1 units
- Distribution
- US: MI, TX, IL
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)