# FDA recall Z-1168-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-01-19.

## Product

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).

## Distribution

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

## Key facts

- **Recall number:** Z-1168-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-19
- **Report date:** 2018-03-28
- **Termination date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westlake Village, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2018

## Citation

> AI Analytics. FDA recall Z-1168-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1168-2018. Source: US FDA. Licensed CC0.

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