# FDA recall Z-2963-2018

> **Zimmer Dental Inc** · Class II · device recall initiated 2018-05-10.

## Product

Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10.      Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

## Reason for recall

Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

## Distribution

Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy,  Portugal, and Spain.

## Key facts

- **Recall number:** Z-2963-2018
- **Recalling firm:** Zimmer Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-10
- **Report date:** 2018-09-12
- **Termination date:** 2020-08-19

- **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-2963-2018

## Citation

> AI Analytics. FDA recall Z-2963-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2963-2018. Source: US FDA. Licensed CC0.

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