Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom Unity Total Knee System. Used for knee prosthesis in total knee replacement Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
Lot Codes / Batch Numbers
Model Number: 112.040.06, Lot Number: 504337
Products Sold
Model Number: 112.040.06; Lot Number: 504337
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom is recalling Unity Total Knee System. Used for knee prosthesis in total knee replacement due to The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packagi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Recommended Action
Per FDA guidance
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.
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
IN, PR
Page updated: Jan 10, 2026