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Miami Device Solutions, LLC. recalls Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of
Recalled December 11, 2019 · FDA recall Z-0603-2020 · Miami Device Solutions
Hazard
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left. · FDA Class II
Units
15 units
Sold at
US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
Description
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
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.
Manufacturer(s)
Miami Device Solutions, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →