# FDA recall Z-0599-2020

> **Toby Orthopaedics, Inc.** · Class II · device recall initiated 2013-06-05.

## Product

PANTERA Proximal Humerus Fracture Plate System

## Reason for recall

Potential suture clip breaking during a humerus fixation surgery.

## Distribution

Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK

## Key facts

- **Recall number:** Z-0599-2020
- **Recalling firm:** Toby Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2013-06-05
- **Report date:** 2019-12-11
- **Termination date:** 2020-09-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0599-2020

## Citation

> AI Analytics. FDA recall Z-0599-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0599-2020. Source: US FDA. Licensed CC0.

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