# FDA recall Z-0018-2020

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-08-08.

## Product

ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile.  The mislabeled model/part number on the vial cap is 835216.    The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are 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

Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

## Distribution

Worldwide distribution - US Nationwide including  the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.

## Key facts

- **Recall number:** Z-0018-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2019-10-09
- **Termination date:** 2019-10-07

- **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-0018-2020

## Citation

> AI Analytics. FDA recall Z-0018-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0018-2020. Source: US FDA. Licensed CC0.

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