FDA Device

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Hazard

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

What You Should Do

Remedy

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.

Products

Unity Total Knee System. Used for knee prosthesis in total knee replacement
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
UPC
Model Number: 112.040.06; Lot Number: 504337

Units Affected

4 devices