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-1828-2016
• Recall Event ID: 74038
• 510(K)Number: K123485 K110879 K110146 K110145 K083070
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: Various trauma and sports medicine instruments and implants.; Fastener, fixation, nondegradable, soft tissue.
• Code Information: Part #'s 904414 904723 904727 904754 904755 904781 904834 912029 912030 912031 912037 912046 912050 912057 912068 912069 912071 912073 912076 912077 912082 912091 916036 110003172 110003182 110005093 110005096 110005198 110005306 110005307 110016992 912036R 912036R 912037R 912040R 912141C Lot #'s 625480 673840 763780 652380 652400 652420 652430 652440 656180 607100 563710 563720 625660 654830 654850 654870 649000 649010 649030 649040 649050 649060 649070 649080 649100 654420 654480 654490 654500 654590 654600 654610 654680 676910 676920 676930 677020 655030 530920 579450 579460 579480 579490 579500 579510 579520 579530 579540 649150 649160 655050 655100 677120 677130 677150 677160 677170 677180 649880 649930 649960 649990 677340 650010 650050 628350 677980 657260 657280 657290 722500 649490 649520 649550 649580 649600 649620 649630 655160 649830 649850 678220 678230 678260 678280 655220 664610 676800 676810 676940 676950 677480
• 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 = MBI and Original Applicant = BIOMET SPORTS MEDICINE; 510(K)s with Product Code = MBI and Original Applicant = BIOMET, INC.; 510(K)s with Product Code = MBI and Original Applicant = TANGSHAN KAIYUE GLOVE CO., LTD.