Miami Device Solutions, LLC.: Medical Device Recall in 2019 - (Recall #: Z-0603-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 15, 2019

Date Posted: December 11, 2019

Recall Number: Z-0603-2020

Event ID: 84230

Reason for Recall:

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

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot number PM00208

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated