FDA-Device2023-02-01Class II
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Biomet, Inc.
Hazard
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Sold states
Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
Affected count
7 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2023Don't want to check this manually?
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