# FDA recall Z-0007-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2017-07-21.

## Product

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile  Dental Implant component.

## Reason for recall

The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

## Distribution

Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

## Key facts

- **Recall number:** Z-0007-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2017-10-11
- **Termination date:** 2021-04-01

- **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-0007-2018

## Citation

> AI Analytics. FDA recall Z-0007-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0007-2018. Source: US FDA. Licensed CC0.

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