Z-1779-2021 Class II Terminated
FDA device recall Z-1779-2021 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: 27 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
- 27 units
Product Description
REF 4890 SMARTSCRAPER 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: 1-35319