Z-1777-2021 Class II Terminated
FDA device recall Z-1777-2021 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: 1,692.
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
- 1,692
Product Description
REF 4049 MICROSS, 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 Pattern
Distribution in US states of Texas and Florida
Code Information
Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118