# FDA recall Z-0603-2020

> **Miami Device Solutions, LLC.** · Class II · device recall initiated 2019-01-15.

## Product

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.

## Reason for recall

Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

## Distribution

US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.

## Key facts

- **Recall number:** Z-0603-2020
- **Recalling firm:** Miami Device Solutions, LLC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-12-11
- **Termination date:** 2020-12-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2020

## Citation

> AI Analytics. FDA recall Z-0603-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0603-2020. Source: US FDA. Licensed CC0.

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