Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail S
FDA device recall Z-2012-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- Customer complaint received regarding the separation of the mallet handle during a medical procedure.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FZY
- Quantity affected
- 38 mallets
- Distribution
- Product was distributed to 20 Biomet sales representatives and distributors nationwide.
- Date initiated
- 2008-05-07
- Date posted
- 2008-09-16
- Date terminated
- 2008-10-22
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.