Biomet, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1815-2016)

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. guide, surgical, instrument

Product Classification:

Class II

Date Initiated: April 1, 2016

Date Posted: June 1, 2016

Recall Number: Z-1815-2016

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 281001080 281001100 35-351208 35-351534 35-351564 Lot #'s 606200 606210 606220 614280 661690 661700 661660 755290 764390 764400 621850

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