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U.S. Department of Health and Human Services

Class 2 Device Recall Corin BIOLOX DELTA MOD HEAD

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  Class 2 Device Recall Corin BIOLOX DELTA MOD HEAD see related information
Date Initiated by Firm January 25, 2021
Create Date March 22, 2021
Recall Status1 Terminated 3 on November 23, 2022
Recall Number Z-1290-2021
Recall Event ID 87293
510(K)Number K130343  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
Code Information Model:104.3215/Lot number:464664
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
Manufacturer Reason
for Recall		 The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm contacted their consignee by email on 01/25/2021. The distributor was instructed to identify the affected product in its inventory and return it to Corin USA in order to contain the part. A recall letter will be sent and acknowledgement of receipt will be requested.
Quantity in Commerce 23 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
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 = MEH and Original Applicant = CORIN U.S.A.
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