RecallRadar

FDA Device recall Z-2405-2021

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

On 2021-09-08 the FDA classified a Class II recall of Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 by Clarus Medical, citing the sterile barrier seal may be compromised.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2405-2021
ClassificationClass II
Statusterminated
Initiated2021-07-27
Published2021-09-08
Last updated2026-09-13 11:56 UTC
CompanyClarus Medical
Distributionn/a

Product

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

Reason

The sterile barrier seal may be compromised.

Identifiers

code_infoModel Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022

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-2405-2021%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.