Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Brand
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
Lot Codes / Batch Numbers
UDI/DI (01) 0 5055196 96833 2, Lot 503150
Products Sold
UDI/DI (01) 0 5055196 96833 2, Lot 503150
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom is recalling Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 due to The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026