Skip to content
Recall Observatory FDA recall evidence

Device product

6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

Z-0618-2021

November 25, 2020

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 86896
Status
Terminated
Classification
Class II
Quantity
7428
Official record key
device-enforcement:Z-0618-2021

Official wording

Reason: 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.

Code information: Lots 167600 288790 286450 368030 180660 285790 285800 179940 179960 179980 180020 288880 288890 288750 179750

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility