Miami Device Solutions, LLC. recalls Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of…

Recall date

January 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0603-2020

FDA classification

Class II

Brand / firm

Miami Device Solutions, LLC.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.