Z-1828-2016 Class II Terminated
FDA device recall Z-1828-2016 was initiated by Biomet, Inc. on Apr 1, 2016 and is designated Class II. 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… The recall status is terminated (terminated May 23, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Apr 1, 2016
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
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.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1828-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026