Unity Total Knee System. Used for knee prosthesis in total knee replacement
- Recall Initiated
- October 31, 2022
- Posted
- November 21, 2022
- Terminated
- January 12, 2024
- Recall Number
- Z-0273-2023
- Quantity
- 4 devices
Reason for Recall
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Distribution
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Lot / Code Info
Model Number: 112.040.06; Lot Number: 504337
Root Cause
Under Investigation by firm
Action Taken
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 vigilance@coringroup.com. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to vigilance@coringroup.com.