Recall Z-0837-2019 ยท LXH Orthopedic Manual Surgical Instrument
OMNIlife science Inc.
OMNI K1 Broach Handle, Product Code HS-10054
| Date | Nov 29, 2018 |
| Status | Terminated |
| Reason | There is a potential for the inner pin of the handle to become loose and fall out. |
| Root cause | Under Investigation by firm |
| Action | Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18. |
| Quantity | 7 |
| Distribution | The products were distributed to the following US states: CA, GA, SC, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.