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U.S. Department of Health and Human Services

Class 2 Device Recall TRIFIT CF

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 Class 2 Device Recall TRIFIT CFsee related information
Date Initiated by FirmMay 06, 2021
Create DateJune 11, 2021
Recall Status1 Terminated 3 on July 05, 2023
Recall NumberZ-1851-2021
Recall Event ID 87959
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
ProductCorin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Code Information Lot Number 467881
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
ActionCorin 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 Commerce1 unit
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC 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.
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