RecallRadar

FDA Device recall Z-0146-2022

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

On 2021-10-27 the FDA classified a Class II recall of Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 by Adria Srl, citing the recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0146-2022
ClassificationClass II
Statusterminated
Initiated2021-05-17
Published2021-10-27
Last updated2026-09-13 11:56 UTC
CompanyAdria Srl
DistributionNJ, NY

Product

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

Reason

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

Identifiers

code_infoLot Number: AD0063/20 AD0313/20 AD0302/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.