# FDA recall Z-0551-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-06-05.

## Product

Zimmer Natural Nail System Tear Drop Guide Wire  2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.

## Reason for recall

The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

## Distribution

Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore

## Key facts

- **Recall number:** Z-0551-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-05
- **Report date:** 2018-02-14
- **Termination date:** 2019-04-17

- **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-0551-2018

## Citation

> AI Analytics. FDA recall Z-0551-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0551-2018. Source: US FDA. Licensed CC0.

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