Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- Recall Initiated
- November 8, 2022
- Posted
- December 19, 2022
- Recall Number
- Z-0727-2023
- Quantity
- 12 units
Reason for Recall
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Distribution
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Lot / Code Info
UDI/DI (01) 0 5055196 96834, Lot 503151
Root Cause
Under Investigation by firm
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