Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SwishPlus Implant Intended for use in support for fixed bridgework. Recalled by Implant Direct Sybron Manufacturing, LLC Due to The extender that is packaged with the SwishTapered"...

Date: January 19, 2018
Company: Implant Direct Sybron Manufacturing, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.

Affected Products

SwishPlus Implant Intended for use in support for fixed bridgework.

Quantity: 1,117 units total

Why Was This 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).

Where Was This Sold?

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

About Implant Direct Sybron Manufacturing, LLC

Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report