Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0616-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

Product Classification:

Class II

Date Initiated: November 25, 2020

Date Posted: December 23, 2020

Recall Number: Z-0616-2021

Event ID: 86896

Reason for Recall:

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Status: Terminated

Product Quantity: 7,428 units

Code Information:

Lots 180140 180150 180160 371180 371190 371250

Distribution Pattern:

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Voluntary or Mandated:

Voluntary: Firm initiated