Date Initiated by Firm | May 06, 2021 |
Create Date | June 11, 2021 |
Recall Status1 |
Terminated 3 on July 05, 2023 |
Recall Number | Z-1851-2021 |
Recall Event ID |
87959 |
Product Classification |
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
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Product | Corin 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
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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 | 1 unit |
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. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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