# FDA recall Z-0198-2022

> **Implant Direct Sybron Manufacturing LLC** · Class II · device recall initiated 2021-09-23.

## Product

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

## Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

## Key facts

- **Recall number:** Z-0198-2022
- **Recalling firm:** Implant Direct Sybron Manufacturing LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-23
- **Report date:** 2021-11-10

- **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-0198-2022

## Citation

> AI Analytics. FDA recall Z-0198-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0198-2022. Source: US FDA. Licensed CC0.

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