Device product
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Z-1776-2021
Product summary
- Firm
- Meta C.G.M. Spa
- Event
- Event 87866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,370 units
- Official record key
device-enforcement:Z-1776-2021
Official wording
Reason: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Code information: Lot number: 10-10719, 25-31118, 23-27018, 16-17118, 15-17018, 2-01521, 23-26620, 23-26820, 17-17920, 7-06519, 17-19818, 17-19818, and 13-12818
Distribution pattern: Distribution in US states of Texas and Florida
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized