Class 2 Device Recall Biomet Polaris 5.5

• Date Initiated by Firm: September 29, 2012
• Date Posted: December 17, 2012
• Recall Status: Terminated on December 07, 2015
• Recall Number: Z-0536-2013
• Recall Event ID: 63653
• Product Classification: Screwdriver - Product Code HXX
• Product: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
• Code Information: Lot Numbers 540199, 540199-1
• Recalling Firm/ Manufacturer: Ebi, Llc; 100 Interpace Pkwy; Parsippany NJ 07054-1149
• For Additional Information Contact: Mr. David M. Talish; 973-299-9300
• Manufacturer Reason for Recall: Broken screw insertor hardness was measured and found to be below the acceptable limits.
• FDA Determined Cause: Process control
• Action: Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
• Quantity in Commerce: 15 units
• Distribution: Nationwide Distribution, including the states of MO, TX, and IN.
• 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.