FDA

Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health

In the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, the FDA describes key actions it will take in the following areas:

  • Establish a robust medical device patient safety net in the United States
  • Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  • Spur innovation towards safer medical devices
  • Advance medical device cybersecurity
  • Integrate the Center for Devices and Radiological Health's (CDRH's) premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety

Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:
•Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
•Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
•Product Code: KWS, PAO
•Lot Numbers: All lots with part number 115340; See full list of lot numbers
•Distribution Dates: October, 2008 to September, 2015
•Manufacturing Dates: August 25, 2008 to September 27, 2011
•Devices Recalled: 3662