# FDA recall Z-1035-2022

> **Arthrex, Inc.** · Class II · device recall initiated 2022-03-25.

## Product

K-Wire, 1.35 mm x 170 mm

## Reason for recall

Products do not meet length and diameter specifications.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

## Key facts

- **Recall number:** Z-1035-2022
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-25
- **Report date:** 2022-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2022

## Citation

> AI Analytics. FDA recall Z-1035-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1035-2022. Source: US FDA. Licensed CC0.

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