Device product
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Z-1777-2021
Product summary
- Firm
- Meta C.G.M. Spa
- Event
- Event 87866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,692
- Official record key
device-enforcement:Z-1777-2021
Official wording
Reason: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Code information: Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118
Distribution pattern: Distribution in US states of Texas and Florida
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized