# FDA recall Z-1189-2018

> **Zimmer Dental Inc** · Class II · device recall initiated 2017-11-29.

## Product

Tapered Screw-Vent MTX, Dental Implant, sterile.  Model TSVTB10.

## Reason for recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

## Distribution

Worldwide distribution  US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

## Key facts

- **Recall number:** Z-1189-2018
- **Recalling firm:** Zimmer Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-04-04
- **Termination date:** 2019-02-08

- **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-1189-2018

## Citation

> AI Analytics. FDA recall Z-1189-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1189-2018. Source: US FDA. Licensed CC0.

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