# FDA recall Z-2140-2019

> **Biomet 3i, LLC** · Class II · device recall initiated 2019-02-26.

## Product

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

## Reason for recall

During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

## Distribution

Nationwide and Puerto Rico, Canada, and Australia

## Key facts

- **Recall number:** Z-2140-2019
- **Recalling firm:** Biomet 3i, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-26
- **Report date:** 2019-08-14
- **Termination date:** 2020-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palm Beach Gardens, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2019

## Citation

> AI Analytics. FDA recall Z-2140-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2140-2019. Source: US FDA. Licensed CC0.

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