Zimmer Biomet, Inc. recalls Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Tota…
- Recall date
- August 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3249-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Why it was recalled
The implant only has one bolt in the sterile package but it should have had two.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
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