# FDA recall Z-3159-2017

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-05-22.

## Product

M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.

## Reason for recall

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly.  The anomaly may be on or below the surface and can increase the risk of instrument fracture.

## Distribution

Nationwide in USA; Internationally to: Australia, Brazil, Canada, China,  El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

## Key facts

- **Recall number:** Z-3159-2017
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-10-04
- **Termination date:** 2019-03-29

- **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-3159-2017

## Citation

> AI Analytics. FDA recall Z-3159-2017. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-3159-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*