FDA-Device2018-03-28Class II
SwishTapered Implant Intended for use in support for fixed bridgework.
Implant Direct Sybron Manufacturing, LLC
Hazard
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Sold states
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Affected count
1,117 units total
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
SwishTapered Implant Intended for use in support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2018Don't want to check this manually?
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