# FDA recall Z-1380-2021

> **Arthrex, Inc.** · Class II · device recall initiated 2021-03-11.

## Product

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

## Reason for recall

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

## Key facts

- **Recall number:** Z-1380-2021
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-11
- **Report date:** 2021-04-21
- **Termination date:** 2024-10-29

- **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-1380-2021

## Citation

> AI Analytics. FDA recall Z-1380-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1380-2021. Source: US FDA. Licensed CC0.

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