Class 2 Device Recall Slotted Mallet

• Date Initiated by Firm: May 07, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on October 22, 2008
• Recall Number: Z-2012-2008
• Recall Event ID: 48158
• Product Classification: Surgical Hammer - Product Code FZY
• 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.
• Code Information: Lot numbers 502398, 503684; Catalog number: 14-442053-00
• FEI Number: 2242816
• Recalling Firm/ Manufacturer: EBI, L.P.; 100 Interpace Pkwy; Parsippany NJ 07054-1149
• For Additional Information Contact: William Hennig; 973-299-9300 Ext. 1557
• Manufacturer Reason for Recall: Customer complaint received regarding the separation of the mallet handle during a medical procedure.
• FDA Determined 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 in Commerce: 38 mallets
• Distribution: Product was distributed to 20 Biomet sales representatives and distributors nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.