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U.S. Department of Health and Human Services

Class 2 Device Recall Corin BIOLOX Delta Modular Femoral Heads

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  Class 2 Device Recall Corin BIOLOX Delta Modular Femoral Heads see related information
Date Initiated by Firm November 08, 2022
Date Posted December 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-0727-2023
Recall Event ID 91183
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Code Information UDI/DI (01) 0 5055196 96834, Lot 503151
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact Dardan Uka
441285659866
Manufacturer Reason
for Recall		 The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued a FIELD SAFETY NOTICE/RECALL LETTER on 11/08/2022 by email. The notice explained the issue, potential risk to health, and post implantation recommendations. The following actions were requested: - Return the device from the filed to Coring USA Limited, Paramount Drive, Raynham, MA 02767, USA - Complete the acknowledgment of receipt and forward to vigilance@coringroup.com to confirm receipt of the Field Safety Notice/Recall Letter. For further information concerning this event, contact: vigilance@coringroup.com
Quantity in Commerce 12 units
Distribution US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
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.
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