FDA-Device2021-09-08Class II
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Clarus Medical, Llc
Hazard
The sterile barrier seal may be compromised.
Sold states
Distribution in US - 18 accounts 1 foreign account
Affected count
858 units
Manufactured in
13355 10th Ave N Ste 110, N/A, Minneapolis, MN, United States
Products
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2021Don't want to check this manually?
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