Z-1844-2021Class II

Quanta System Sterile Optical Laser Fiber, reusable

Name: Z-1844-2021 Quanta System Sterile Optical Laser Fiber, reusable
Creator: Quanta System, S.p.A.
Published: 2021-04-27
License: https://open.fda.gov/license/

Quanta System Inc. / initiated 2021-04-27 / Terminated / root cause: manufacturing process

FDA source

Quanta System, S.p.A. began a recall of Quanta System Sterile Optical Laser Fiber, reusable on 2021-04-27. FDA classified it as Class II and gives the reason as "Product sterility is potentially compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1844-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-27
Posted: 2021-06-10
Terminated: 2023-09-05
Recalling firm: Quanta System Inc.
Product: Quanta System Sterile Optical Laser Fiber, reusable
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product sterility is potentially compromised.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
Quantity in commerce: 307
Distribution: Nationwide distribution via 6 US distributors
Product codes and lots: Product Part Numbers: OAF002013 Lots A201003 OAF005513 Lots A184636, A192118, A193101 OAF006003 Lot A195008 OAF008003 Lots A193615, A194021 OAF008013 Lots A183623, A192119 OAF009903 Lots A193109, A193617 OAF009913 Lots A181350, A192910 OAF702713 Lots A182415, A193104, A194109, A194723 OAF703613 Lot A180150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1844-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1842-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09
Z-1843-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09
Z-1844-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code GEX

K160513Class IIQuanta System Surgical Laser fibersQuanta System Spa / cleared 2016-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)