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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Lot Codes / Batch Numbers
Lot numbers 502398, 503684, Catalog number: 14-442053-00
Products Sold
Lot numbers 502398, 503684; Catalog number: 14-442053-00
A medical device manufacturer is recalling Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the due to Customer complaint received regarding the separation of the mallet handle during a medical procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customer complaint received regarding the separation of the mallet handle during a medical procedure.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026