Recall Z-0837-2019— OMNIlife science Inc.
Class II · Terminated
Class II FDA medical device recall by OMNIlife science Inc., initiated 2018-11-29, terminated 2020-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: OMNI K1 Broach Handle, Product Code HS-10054. Reason: There is a potential for the inner pin of the handle to become loose and fall out..
- Recalling firm
- OMNIlife science Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-29
- Terminated
- 2020-04-16
- Firm location
- Raynham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.