Recall Z-0727-2023— Corin Ltd

Class II · Ongoing

Class II FDA medical device recall by Corin Ltd, initiated 2022-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615. Reason: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa..

Recalling firm
Corin Ltd
Classification
Class II
Status
Ongoing
Initiated
2022-11-08
Firm location
Cirencester, United Kingdom

Product description

Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

Reason for recall

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

Data sourced from openFDA. This site is unofficial and independent of the FDA.