FDA recall Z-0727-2023

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