FDA-Device2020-12-23Class II
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.
Biomet, Inc.
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.
Sold states
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Affected count
7428
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0624-2021Don't want to check this manually?
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