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Class 2 Device Recall Corin BIOLOX Delta Modular Femoral Heads |
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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
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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
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For Additional Information Contact |
Dardan Uka 441285659866
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Manufacturer Reason for Recall |
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
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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
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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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