# FDA recall Z-1917-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-03-14.

## Product

ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile.  Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL.      Product Usage: Usage:  Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

## Reason for recall

The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

## Distribution

Worldwide Distribution - US Nationwide in the state of  AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI.   Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.

## Key facts

- **Recall number:** Z-1917-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-14
- **Report date:** 2018-05-30
- **Termination date:** 2018-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Thousand Oaks, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1917-2018

## Citation

> AI Analytics. FDA recall Z-1917-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1917-2018. Source: US FDA. Licensed CC0.

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