| Class 2 Device Recall Unity Total Knee System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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