# FDA recall Z-1920-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2016-11-15.

## Product

ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile.  The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

## Reason for recall

The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct.  The main vial label was correctly labeled.

## Distribution

Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA.  There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-1920-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-11-15
- **Report date:** 2018-05-30
- **Termination date:** 2018-06-04

- **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-1920-2018

## Citation

> AI Analytics. FDA recall Z-1920-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-1920-2018. Source: US FDA. Licensed CC0.

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