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Recall Observatory FDA recall evidence

Device product

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

Z-2405-2021

July 27, 2021

Class II

Product summary

Firm
Clarus Medical, Llc
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

    reason.sterility_assurance · v1.0.0

    sterile barrier seal may be compromised