# FDA recall Z-0364-2020

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2019-08-09.

## Product

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA    Dental Implants

## Reason for recall

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

## Distribution

U.S.: IN, VA, MD, TX, WA  OUS: Japan

## Key facts

- **Recall number:** Z-0364-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-09
- **Report date:** 2019-11-20
- **Termination date:** 2021-04-27

- **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-0364-2020

## Citation

> AI Analytics. FDA recall Z-0364-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0364-2020. Source: US FDA. Licensed CC0.

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