Implant Direct Sybron Manufacturing, LLC recalls SwishPlus Implant Intended for use in support for fixed bridgework.
- Recall date
- January 19, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1168-2018
- FDA classification
- Class II
- Brand / firm
- Implant Direct Sybron Manufacturing, LLC
- Sold / distributed
- Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Why it was recalled
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SwishPlus Implant Intended for use in support for fixed bridgework.
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