Z-0837-2019 Class II Terminated
FDA device recall Z-0837-2019 was initiated by OMNIlife science Inc. on November 29, 2018 and is designated Class II. Reason for recall: There is a potential for the inner pin of the handle to become loose and fall out. The recall status is terminated (terminated April 16, 2020). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- November 29, 2018
- Termination Date
- April 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
OMNI K1 Broach Handle, Product Code HS-10054
Reason for Recall
There is a potential for the inner pin of the handle to become loose and fall out.
Distribution Pattern
The products were distributed to the following US states: CA, GA, SC, and UT.
Code Information
Lot Number MM0118