Recall Z-2012-2008 ยท FZY Hammer, Surgical
EBI, L.P.
Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correcti
| Date | Sep 16, 2008 (initiated May 7, 2008) |
| Status | Terminated |
| Reason | Customer complaint received regarding the separation of the mallet handle during a medical procedure. |
| Root cause | Process control |
| Action | Recall letters were sent to Sales reps and distributors on May 7, 2007. Questions should be directed to William Hennig, QA Manager at 973-299-9300. |
| Quantity | 38 mallets |
| Distribution | Product was distributed to 20 Biomet sales representatives and distributors nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.