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