Z-2405-2021 Class II Terminated

Recalled by Clarus Medical, Llc — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
July 27, 2021
Termination Date
September 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