FDA-Device2018-10-03Class II
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Zimmer Biomet, Inc.
Hazard
The implant only has one bolt in the sterile package but it should have had two.
Sold states
Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Affected count
16
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3249-2018Don't want to check this manually?
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