Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet

• Date Initiated by Firm: April 01, 2016
• Date Posted: May 26, 2016
• Recall Status: Terminated on May 23, 2017
• Recall Number: Z-1819-2016
• Recall Event ID: 74038
• 510(K)Number: K050118 K871539 K063570 K091976
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Various trauma and sports medicine instruments and implants.; Rod, fixation, intramedullary and accessories.
• Code Information: Part #'s 28234 28338 28811 28813 28821 29260 29822 805065080 14-400428 14-400436 14-405032 14-405040 14-440118 14-440121 14-441280 14-440066S Lot #'s 590970 591080 591090 665210 692040 692250 692280 692290 695900 610470 665230 665240 692440 692450 692480 692620 692660 692670 692690 721680 721720 721730 729080 722730 621840 621860 678300 664740 664820 664870 664880 503760 503770 693840 476230
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Audrey Daenzer; 574-372-1570
• Manufacturer Reason for Recall: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
• FDA Determined Cause: Equipment maintenance
• Action: Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
• Distribution: Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
• 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 = HSB and Original Applicant = BIOMET MANUFACTURING CORP.; 510(K)s with Product Code = HSB and Original Applicant = BIOMET TRAUMA; 510(K)s with Product Code = HSB and Original Applicant = BUCKMAN CO., INC.; 510(K)s with Product Code = HSB and Original Applicant = EBI, L.P.