Device product
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.
Z-0603-2020
Product summary
- Event
- Event 84230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0603-2020
Official wording
Reason: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
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.
Derived failure modes
-
Unknown
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.