Reported Nov 8, 2023 · Ongoing
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Corin Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Corin Ltd · Unit 1-57-8 · Cirencester, N/A · N/A
Is this the product you have?
- Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Lot codes and dates
UDI/DI 05055343872505Lot Number 532405
- Amount recalled
- 1 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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