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
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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.
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