Device product
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Z-1779-2021
Product summary
- Firm
- Meta C.G.M. Spa
- Event
- Event 87866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-1779-2021
Official wording
Reason: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Code information: Lot number: 1-35319
Distribution pattern: Distribution in US states of Texas and Florida
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized