# FDA recall Z-0185-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2017-10-10.

## Product

ImplantDirect  Legacy(TM) 3 Implant, 13MM L, REF 864713    This Legacy implant is a two-piece implant 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

One reported complaint and discovered that the outer vial was out of round and undersized.  Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial.  As a result, the cap could possibly not be screwed on properly and the sterilization compromised.

## Distribution

Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.

## Key facts

- **Recall number:** Z-0185-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-10
- **Report date:** 2017-12-06
- **Termination date:** 2018-09-27

- **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-0185-2018

## Citation

> AI Analytics. FDA recall Z-0185-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0185-2018. Source: US FDA. Licensed CC0.

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