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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