FDA recall Z-0727-2023

Corin Ltd · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.

Key facts

Status
Ongoing
Initiation date
2022-11-08
Report date
2022-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cirencester, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2023