FDA-Device2018-06-20Class II
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Hazard
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
Sold states
Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
Affected count
169
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2183-2018Don't want to check this manually?
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