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U.S. Department of Health and Human Services

Class 2 Device Recall Corin METAFIX HIP STEM

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  Class 2 Device Recall Corin METAFIX HIP STEM see related information
Date Initiated by Firm July 22, 2022
Create Date August 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1509-2022
Recall Event ID 90573
510(K)Number K153381  K082525  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Code Information UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact
441285659866
Manufacturer Reason
for Recall		 One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
FDA Determined
Cause 2		 Process control
Action The firm notified its direct consignees of the recall on 07/22/2022 by letter. The notice explained the issue and requested the following actions: "Actions to be taken by the Customer: - Quarantine the devices if not yet performed - Return the devices to Corin Limited, displaying the RGA note on the exterior of the parcel, to: RA/Vigilance Department; Corin Ltd; Corinium Centre; Cirencester; Gloucestershire; GL7 1YJ, United-Kingdom - Complete the acknowledgement of receipt and forward it to the Vigilance department of Corin UK to confirm receipt of this Field Safety Notice/Recall letter."
Quantity in Commerce 5 devices
Distribution US Nationwide distribution in the states of OK, TX, FL.
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.
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.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = CORIN USA
510(K)s with Product Code = JDI and Original Applicant = Corin USA Limited
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