FDA Medical Device Recalls (openFDA)
Corin Ltd: Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- Recall number
- Z-0727-2023
- Recalling firm
- Corin Ltd
- Product
- Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- Status
- Open, Classified
- Initiated
- 2022-11-08
- Posted
- 2022-12-19
- Terminated
- not on file
- Reason
- The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- Root cause
- 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
- 12 units
- Distribution
- US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
- Lot, serial or model codes
- UDI/DI (01) 0 5055196 96834, Lot 503151
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3002806725
- Firm city
- Cirencester
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28