FDA-Device2021-06-09Class II

REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

Meta C.G.M. Spa
Hazard

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Sold states
Distribution in US states of Texas and Florida
Affected count
8,370 units
Manufactured in
Via Modena 22-24, Correggio, Italy
Products
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2021

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