OMNIlife science Inc.: Medical Device Recall in 2019 - (Recall #: Z-0837-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

OMNI K1 Broach Handle, Product Code HS-10054

Product Classification:

Class II

Date Initiated: November 29, 2018
Date Posted: February 20, 2019
Recall Number: Z-0837-2019
Event ID: 81951
Reason for Recall:

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

Status: Terminated
Product Quantity: 7
Code Information:

Lot Number MM0118

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated