Recall Z-2012-2008
Ebi, L.P. · initiated May 7, 2008
Product
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 correction of deformity and arthrodesis.
Codes / lots: Lot numbers 502398, 503684; Catalog number: 14-442053-00
Reason for recall
Customer complaint received regarding the separation of the mallet handle during a medical procedure.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2012-2008
- Initiated
- May 7, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- October 22, 2008
- Product code
- FZY – Hammer, Surgical
- Quantity
- 38 mallets
- Distribution
- Product was distributed to 20 Biomet sales representatives and distributors nationwide.
- Recalling firm
- Ebi, L.P., Parsippany, NJ