# FDA recall Z-0075-2021

> **Biomet 3i, LLC** · Class II · device recall initiated 2020-08-31.

## Product

CERTAIN BELLATEK TIN ABUTMENT 4.1MM  Reference Number: IEDAN4

## Reason for recall

Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

## Distribution

FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA

## Key facts

- **Recall number:** Z-0075-2021
- **Recalling firm:** Biomet 3i, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-14
- **Termination date:** 2022-07-06

- **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-0075-2021

## Citation

> AI Analytics. FDA recall Z-0075-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0075-2021. Source: US FDA. Licensed CC0.

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