# FDA recall Z-0282-2018

> **Zimmer Dental Inc** · Class II · device recall initiated 2017-10-11.

## Product

Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT.  The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.    Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

## Reason for recall

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0282-2018
- **Recalling firm:** Zimmer Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-11
- **Report date:** 2017-12-27
- **Termination date:** 2019-03-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2018

## Citation

> AI Analytics. FDA recall Z-0282-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0282-2018. Source: US FDA. Licensed CC0.

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