Class 2 Device Recall Artificial ligament fixation device

• Date Initiated by Firm: March 31, 2010
• Date Posted: July 01, 2010
• Recall Status: Terminated on August 06, 2012
• Recall Number: Z-1952-2010
• Recall Event ID: 55776
• 510(K)Number: K083070
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.
• Code Information: Lot Numbers: 047510, 050400, 050420, 089710, 089800, 182820, 192240, 192250, 192280, 219260, 219270, 219280, 228530, 228550, 228580, 228590, 228610, 228620, 295450, 361020, 361020, 392930, 392990, 483490, 483500, 529380, 527780, 529800, 529810, 582890, 582910, 627510, 648470, 648480, 671130, 671150, 671170, 671180, 671190, 671240, 706150, 706160, 782360, 782370, 821710, 821730, 943000, 943010, 943030, 952040, 952070 and 974140.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
• FDA Determined Cause: Process control
• Action: Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.
• Quantity in Commerce: 2466 both products
• Distribution: Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.
• 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 = MBI