# FDA recall Z-0283-2018

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2017-11-15.

## Product

Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK)     Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

## Reason for recall

The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.

## Distribution

Worldwide Distribution - USA (nationwide)  Distribution and to the countries of : Europe, Canada,  Australia, Egypt, Jordan, and Lebanon.

## Key facts

- **Recall number:** Z-0283-2018
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-15
- **Report date:** 2017-12-27
- **Termination date:** 2018-10-09

- **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-0283-2018

## Citation

> AI Analytics. FDA recall Z-0283-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0283-2018. Source: US FDA. Licensed CC0.

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