FDA-Device2019-02-20Class II

OMNI K1 Broach Handle, Product Code HS-10054

OMNIlife science Inc.
Hazard

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

Sold states
The products were distributed to the following US states: CA, GA, SC, and UT.
Affected count
7
Manufactured in
480 Paramount Dr, N/A, Raynham, MA, United States
Products
OMNI K1 Broach Handle, Product Code HS-10054

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2019

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