FDA recall Z-0146-2022

Product

Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749

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-0146-2022