# FDA recall Z-0010-2020

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-08-07.

## Product

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile.  The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

## Reason for recall

The incorrect device was packaged in the vial.

## Distribution

Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX.  There was no government/military distribution.  Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.

## Key facts

- **Recall number:** Z-0010-2020
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-07
- **Report date:** 2019-10-09

- **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-0010-2020

## Citation

> AI Analytics. FDA recall Z-0010-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0010-2020. Source: US FDA. Licensed CC0.

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