Biomet, Inc. recalls OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.

Recalled December 23, 2020 · FDA recall Z-0623-2021 · Biomet

Hazard

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. · FDA Class II

Units

7428

Sold at

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

Description

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.

Product

OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.

Manufacturer(s)

Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →