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U.S. Department of Health and Human Services

Class 2 Device Recall TRIFIT TS

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  Class 2 Device Recall TRIFIT TS see related information
Date Initiated by Firm May 06, 2021
Create Date June 11, 2021
Recall Status1 Completed
Recall Number Z-1850-2021
Recall Event ID 87959
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Code Information Lot Number 465498
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
Manufacturer Reason
for Recall		 Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
FDA Determined
Cause 2		 Under Investigation by firm
Action Corin initiated the recall by email on 05/06/2021 and followed with a letter on 05/07/2021 disseminated by email. The firm is seeking the return of the product.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the state of TX.
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.
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