ADRIA SRL recalls Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

Recall date

May 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0144-2022

FDA classification

Class II

Brand / firm

ADRIA SRL

Sold / distributed

The products were distributed to the following US states: NJ and NY.

Why it was recalled

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715