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U.S. Department of Health and Human Services

Class 2 Device Recall Trinity Acetabular System

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  Class 2 Device Recall Trinity Acetabular System see related information
Date Initiated by Firm July 28, 2021
Create Date September 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-2604-2021
Recall Event ID 88589
510(K)Number K093472  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
Code Information The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.035 - Lot number 481070 was delivered 7/23/2021 and 7/26/2021; and Model 321.050 - Lot number 478892 was delivered 7/23/2021.
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact Ms. Marie-Anne Euzen
441285659866
Manufacturer Reason
for Recall		 The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
FDA Determined
Cause 2		 Storage
Action On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.
Quantity in Commerce 6 units
Distribution US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
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 = MEH and Original Applicant = CORIN U.S.A.
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