Reported Dec 11, 2019 · Terminated

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of…

Miami Device Solutions, LLC.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Miami Device Solutions, LLC. · 7620 Nw 25th St Ste 3 · Miami, FL · 33122-1719

Is this the product you have?

  • Proximal Humerus Plate, 8 holes, Right
  • REF MDS130108R - Product UsageThe 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
Lot codes and dates
  • Lot number PM00208
Amount recalled
15 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 11, 2020 · Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.