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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 Headssee related information
Date Initiated by FirmNovember 08, 2022
Date PostedDecember 19, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0727-2023
Recall Event ID 91183
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductCorin 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 ContactDardan 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
ActionThe 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 Commerce12 units
DistributionUS Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Total Product Life CycleTPLC 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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