Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
Lot Codes / Batch Numbers
UDI/DI 05055343872505, Lot Number 532405.
Products Sold
UDI/DI 05055343872505, Lot Number 532405.
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom is recalling Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty due to 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 v. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MI, TX
Page updated: Jan 10, 2026