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Recall Observatory FDA recall evidence

Device product

OMNI K1 Broach Handle, Product Code HS-10054

Z-0837-2019

November 29, 2018

Class II

Product summary

Firm
OMNIlife science Inc.
Event
Event 81951
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-0837-2019

Official wording

Reason: There is a potential for the inner pin of the handle to become loose and fall out.

Code information: Lot Number MM0118

Distribution pattern: The products were distributed to the following US states: CA, GA, SC, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the inner pin of the handle to become loose and fall out.