Z-1776-2021 Class II Terminated
FDA device recall Z-1776-2021 was initiated by Meta C.G.M. Spa on April 26, 2021 and is designated Class II. Reason for recall: Sterility issues; single use devices labeled as sterile may not have been adequately sterilized The recall status is terminated (terminated September 12, 2024). Affected quantity: 8,370 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 26, 2021
- Termination Date
- September 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,370 units
Product Description
REF 3987, SAFESCRAPER CURVE 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 Pattern
Distribution in US states of Texas and Florida
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