Recall Z-0144-2022— ADRIA SRL

Name: FDA recall Z-0144-2022
Creator: U.S. Food and Drug Administration
Published: 2021-05-17

Class II · Terminated

Class II FDA medical device recall by ADRIA SRL, initiated 2021-05-17, terminated 2023-11-06. It names one FDA 510(k) clearance: K141557. Product: Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715. Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed..

Recalling firm: ADRIA SRL
Classification: Class II
Status: Terminated
Initiated: 2021-05-17
Terminated: 2023-11-06
Firm location: San Giovanni In Persiceto, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K141557 — HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBARGallini Medical Devices, Srl·cleared 2014-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.