Home / Recalls / Clarus Medical, Llc / Z-2405-2021

Z-2405-2021 Class II Terminated

Recalled by Clarus Medical, Llc — Minneapolis, MN

FDA device recall Z-2405-2021 was initiated by Clarus Medical, Llc on Jul 27, 2021 and is designated Class II. Reason for recall: The sterile barrier seal may be compromised. The recall status is terminated (terminated Sep 15, 2022). Affected quantity: 858 units.

Recall Details

Product Type: Devices
Report Date: Sep 8, 2021
Initiation Date: Jul 27, 2021
Termination Date: Sep 15, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 858 units

Product Description

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

Reason for Recall

The sterile barrier seal may be compromised.

Distribution Pattern

Distribution in US - 18 accounts 1 foreign account

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2405-2021
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.