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.

Recall Insight

This FDA Devices action (record #Z-0603-2020) was formally reported on December 11, 2019, with the manufacturer initiating the action on January 15, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Miami Device Solutions, LLC. is listed as the recalling firm, operating out of Miami, FL. Federal records indicate 15 units units are affected.

The documented reason for this recall is: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.