Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA device recall Z-0727-2023 · posted 2022-12-19 · Open, Classified
Recall details
- Recalling firm
- Corin Ltd
- Reason for recall
- The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LZO
- Quantity affected
- 12 units
- Distribution
- US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
- Date initiated
- 2022-11-08
- Date posted
- 2022-12-19
- Location
- Cirencester, United Kingdom
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