Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Proximal Humerus Plate Recalled by Miami Device Solutions, LLC. Due to Right Proximal Humerus Plates. Product component parts MDS130108R,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Miami Device Solutions, LLC. directly.
Affected Products
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.
Quantity: 15 units
Why Was This Recalled?
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Miami Device Solutions, LLC.
Miami Device Solutions, LLC. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report