SwishPlus Implant Intended for use in support for fixed bridgework.
Reported: March 28, 2018 Initiated: January 19, 2018 #Z-1168-2018
Product Description
SwishPlus Implant Intended for use in support for fixed bridgework.
Reason for Recall
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).
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 1,117 units total
- Distribution
- Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
SwishPlus Implant Intended for use in support for fixed bridgework.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 1,117 units total.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 28, 2018. Severity: Moderate. Recall number: Z-1168-2018.
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