Z-1819-2016 Class II Terminated
FDA device recall Z-1819-2016 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. Rod, fixation, intramedullary and accessories.
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 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1819-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026