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Biomet, Inc. recalls Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral comp
Recalled December 23, 2020 · FDA recall Z-0624-2021 · 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
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →