FDA Recall
Open, Classified
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Recall: Z-0726-2023
·
Initiated November 8, 2022
Recall
- Recall Number
- Z-0726-2023
- Event Number
- 91183
- Firm
- Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
- FEI Number
- 3002806725
- Product Code
- LZO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 8, 2022
- Posted
- December 19, 2022
Description
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Reason
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
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 [email protected] to confirm receipt of the Field Safety Notice/Recall Letter. For further information concerning this event, contact: [email protected]
Distribution
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Quantity
5 units