Meta C.G.M. Spa recalls REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

Recalled June 9, 2021 · FDA recall Z-1776-2021 · Meta C.G.M. Spa

Hazard

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized · FDA Class II

Units

8,370 units

Sold at

Distribution in US states of Texas and Florida

Description

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

Product

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

Manufacturer(s)

Meta C.G.M. Spa

Made in

Italy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →