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Terminated

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.

FDA Recall Z-2012-2008 · Posted 2008-09-16

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeFZY
Date Initiated2008-05-07
Date Terminated2008-10-22
Product Quantity38 mallets

Reason for Recall

Customer complaint received regarding the separation of the mallet handle during a medical procedure.

Firm 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.

Root Cause

Process control

Distribution Pattern

Product was distributed to 20 Biomet sales representatives and distributors nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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