FDA recall Z-2405-2021
Clarus Medical, Llc · Class II · device
Product
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
Distribution in US - 18 accounts 1 foreign account
Key facts
- Status
- Terminated
- Initiation date
- 2021-07-27
- Report date
- 2021-09-08
- Termination date
- 2022-09-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2021