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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 13, 2023
Date Posted November 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-0214-2024
Recall Event ID 93144
510(K)Number K113060  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Unity Total Knee System, Model Number 112.001.34.

Primary and revision total knee arthroplasty
Code Information UDI/DI 05055343872505, Lot Number 532405.
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact
441285659866
Manufacturer Reason
for Recall		 Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
FDA Determined
Cause 2		 Process change control
Action Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.
Quantity in Commerce 1 units
Distribution US: MI, TX, IL
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = CORIN U.S.A.
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