Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1819-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.

Product Classification:

Class II

Date Initiated: April 1, 2016

Date Posted: June 1, 2016

Recall Number: Z-1819-2016

Event ID: 74038

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.

Status: Terminated

Product Quantity: N/A

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated