PlainRecalls
FDA Devices Moderate Class II Terminated

REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

Reported: June 9, 2021 Initiated: April 26, 2021 #Z-1779-2021

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

Details

Recalling Firm
Meta C.G.M. Spa
Units Affected
27 units
Distribution
Distribution in US states of Texas and Florida
Location
Correggio

Frequently Asked Questions

What product was recalled?
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.. Recalled by Meta C.G.M. Spa. Units affected: 27 units.
Why was this product recalled?
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Which agency issued this recall?
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1779-2021.