# FDA recall Z-0089-2019

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2018-05-29.

## Product

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform.    Dental implant component, used temporarily during impressions for the prosthetic procedure.

## Reason for recall

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

## Distribution

Worldwide distribution.  US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

## Key facts

- **Recall number:** Z-0089-2019
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-29
- **Report date:** 2018-10-17
- **Termination date:** 2020-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Thousand Oaks, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2019

## Citation

> AI Analytics. FDA recall Z-0089-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0089-2019. Source: US FDA. Licensed CC0.

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