# FDA recall Z-3246-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-07-30.

## Product

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008    Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia:   Compound and simple shaft fractures   Proximal, metaphyseal and distal shaft fractures   Segmental fractures   Comminuted fractures   Fractures involving osteopenic and osteoporotic bone   Pathological fractures   Fractures with bone loss   Pseudoarthrosis, non-union, mal-union and delayed union   Periprosthetic fractures   Surgically created defects such as osteotomies.  Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia:   Compound and simple shaft fractures   Proximal, metaphyseal and distal shaft fractures   Segmental fractures   Comminuted fractures   Fractures involving osteopeni

## Reason for recall

The item is labeled as an 8.3mm, but it is actually a 12 mm.

## Distribution

The product was not distributed in the United States.      The product was distributed in the Netherlands.

## Key facts

- **Recall number:** Z-3246-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-30
- **Report date:** 2018-10-03
- **Termination date:** 2019-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3246-2018

## Citation

> AI Analytics. FDA recall Z-3246-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3246-2018. Source: US FDA. Licensed CC0.

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