Recall Z-1844-2021— Quanta System, S.p.A.

Name: FDA recall Z-1844-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-27

Class II · Terminated

Class II FDA medical device recall by Quanta System, S.p.A., initiated 2021-04-27, terminated 2023-09-05. It names one FDA 510(k) clearance: K160513. Product: Quanta System Sterile Optical Laser Fiber, reusable. Reason: Product sterility is potentially compromised..

Recalling firm: Quanta System, S.p.A.
Classification: Class II
Status: Terminated
Initiated: 2021-04-27
Terminated: 2023-09-05
Firm location: Samarate, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K160513 — Quanta System Surgical Laser fibersQuanta System Spa·cleared 2016-03-18

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

Quanta System Sterile Optical Laser Fiber, reusable

Reason for recall

Product sterility is potentially compromised.

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