FDA recall Z-1778-2021

Meta C.G.M. Spa · Class II · device

Product

REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

Reason for recall

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Distribution

Distribution in US states of Texas and Florida

Key facts

Status: Terminated
Initiation date: 2021-04-26
Report date: 2021-06-09
Termination date: 2024-09-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Correggio, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1778-2021