Z-2405-2021Class II

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

Name: Z-2405-2021 Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Creator: Clarus Medical, Llc
Published: 2021-07-27
License: https://open.fda.gov/license/

Clarus Medical, LLC / initiated 2021-07-27 / Terminated / root cause: packaging

FDA source

Clarus Medical, Llc began a recall of Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 on 2021-07-27. FDA classified it as Class II and gives the reason as "The sterile barrier seal may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2405-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-27
Posted: 2021-09-03
Terminated: 2022-09-15
Recalling firm: Clarus Medical, LLC
Product: Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The sterile barrier seal may be compromised.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The affected Domestic customers, Domestic/International Distributors will be notified with a Field Safety Notice. Domestic/International distributors will also include a request for a list of the Distributor s customers.
Quantity in commerce: 858 units
Distribution: Distribution in US - 18 accounts 1 foreign account
Product codes and lots: Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02

Product code GEX

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)