2 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Recall
Terminated
·Miami Device Solutions, LLC.·Product code HRS·January 15, 2019
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.
FDA Enforcement
Class II
·Terminated·Miami Device Solutions, LLC.·December 11, 2019