FDA recall Z-1779-2021
Meta C.G.M. Spa · Class II · device
Product
REF 4890 SMARTSCRAPER CE0123, 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-1779-2021