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U.S. Department of Health and Human Services

Class 2 Device Recall Unity Total Knee System

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  Class 2 Device Recall Unity Total Knee System see related information
Date Initiated by Firm October 31, 2022
Date Posted November 21, 2022
Recall Status1 Terminated 3 on January 12, 2024
Recall Number Z-0273-2023
Recall Event ID 91039
510(K)Number K113060  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Unity Total Knee System.

Used for knee prosthesis in total knee replacement
Code Information Model Number: 112.040.06; Lot Number: 504337
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact
441285659866
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 4 devices
Distribution Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = CORIN U.S.A.
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