Class 3 Device Recall Biomet Graft Preparation System

• Date Initiated by Firm: June 11, 2007
• Date Posted: July 04, 2007
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0993-2007
• Recall Event ID: 38116
• 510(K)Number: K021071
• Product Classification: bone graft preparation syringe - Product Code FMF
• Product: Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300.
• Code Information: Lots 192180, exp. Jan 2012; 223260, exp. Jan 2012 and 652330, exp May 2011.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46581-0587
• For Additional Information Contact: 574-267-6639
• Manufacturer Reason for Recall: The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
• Quantity in Commerce: 46 to U.S. and international
• Distribution: Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
• 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.

• 510(K) Database: 510(K)s with Product Code = FMF and Original Applicant = BIOMET, INC.