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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 January 29, 2016
Create Date April 22, 2016
Recall Status1 Terminated 3 on December 16, 2019
Recall Number Z-1527-2016
Recall Event ID 73205
510(K)Number K123705  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Trinity Acetabular Shell

Product Usage: Total Hip Replacement.
Code Information Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:
Recalling Firm/
Manufacturer		 Corin USA Limited
5670 W Cypress St Ste C
Tampa FL 33607-1774
For Additional Information Contact Magnus Flett
813-977-4469
Manufacturer Reason
for Recall		 Potential for abrasion of the sterile barrier pouches of the new packaging system.
FDA Determined
Cause 2		 Packaging process control
Action Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time
Quantity in Commerce 629 devices in total
Distribution Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = CORIN USA
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