Device product
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Z-2405-2021
Product summary
- Event
- Event 88399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 858 units
- Official record key
device-enforcement:Z-2405-2021
Official wording
Reason: The sterile barrier seal may be compromised.
Code information: Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022
Distribution pattern: Distribution in US - 18 accounts 1 foreign account
Derived failure modes
-
Sterility assurance
sterile barrier seal may be compromised