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Implant Direct Sybron Manufacturing, LLC recalls SwishPlus Implant Intended for use in support for fixed bridgework.
Recalled March 28, 2018 · FDA recall Z-1168-2018 · Implant Direct Sybron Manufacturing
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). · FDA Class II
Units
1,117 units total
Sold at
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Description
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).
Product
SwishPlus Implant Intended for use in support for fixed bridgework.
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →