FDA recall Z-0603-2020

Miami Device Solutions, LLC. · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-01-15
Report date
2019-12-11
Termination date
2020-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0603-2020