# FDA recall Z-3115-2017

> **Implant Direct Sybron Manufacturing, LLC** · Class II · device recall initiated 2017-06-26.

## Product

Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883.    The Guided Handle Kit (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 consist 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 inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of :  AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of :  Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.

## Key facts

- **Recall number:** Z-3115-2017
- **Recalling firm:** Implant Direct Sybron Manufacturing, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-26
- **Report date:** 2017-09-20
- **Termination date:** 2021-06-16

- **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-3115-2017

## Citation

> AI Analytics. FDA recall Z-3115-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3115-2017. Source: US FDA. Licensed CC0.

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