# FDA recall Z-2242-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-05-16.

## Product

3.2MM X 560MM COCR THD TIP; 14-441053     Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

## Reason for recall

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

## Key facts

- **Recall number:** Z-2242-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-16
- **Report date:** 2018-06-27
- **Termination date:** 2024-04-05

- **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-2242-2018

## Citation

> AI Analytics. FDA recall Z-2242-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2242-2018. Source: US FDA. Licensed CC0.

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