FDA recall Z-0144-2022

ADRIA SRL · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-05-17
Report date
2021-10-27
Termination date
2023-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Giovanni In Persiceto, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0144-2022