Unity Total Knee System recallZ-0214-2024 · Corin Ltd · initiated Oct 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Corin Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0214-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2023
- Posted by the FDA
- Nov 2, 2023
- Recalling firm
- Corin Ltd
- Quantity
- 1 units
- Product code
- JWH
- FDA submissions
- K113060
- Distribution
- US: MI, TX, IL
Product description
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Code information (models, lots, serial numbers)
UDI/DI 05055343872505, Lot Number 532405.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Unity Total Knee System 112.001.34Corin Ltd · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K113060 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Unity Total Knee System 112.001.32Corin Ltd · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Unity Total Knee System 112.014.82Corin Ltd · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Unity Total Knee System 112.016.85Corin Ltd · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 93144).
- Z-0213-2024 · Open, ClassifiedUnity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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