Unity Total Knee System recallZ-0273-2023 · Corin Ltd · initiated Oct 31, 2022
Class II Terminated All recalls posted in November 2022
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
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
FDA root cause category: Under Investigation by firm
What the company is doing
Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to [email protected]. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to [email protected].
Recall details
- Recall number
- Z-0273-2023
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 31, 2022
- Posted by the FDA
- Nov 21, 2022
- Recalling firm
- Corin Ltd
- Quantity
- 4 devices
- Product code
- JWH
- FDA submissions
- K113060
- Distribution
- Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Product description
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Code information (models, lots, serial numbers)
Model Number: 112.040.06; Lot Number: 504337
Other devices under the same FDA submission
4 devices cleared under K113060 — the recall does not name any of them by identifier. 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 112.001.34Corin 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
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 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page