A Class 1 recall by the Food and Drug Administration (FDA) is the most serious type of recall issued by the FDA. Medical devices recalled in this manner may cause serious injury or death.
The FDA has recently announced a Class 1 recall of the Zimmer Biomet Comprehensive Reverse Shoulder. The product description is listed as the "Comprehensive Reverse Shoulder System Humeral Tray Model 115340." The affected product codes are KWS and PAO, with several lots of part number 115340. The device was distributed between Oct 2008 and September 2005, with manufacturing dates of Aug. 25, 2008 to Sept. 27, 2011. The recall affects 3,662 devices.
This devices is used for complete shoulder replacements in order to help restore arm movement. It is often used on patients with rotator cuff tears who have also developed arthropathy, which is a type of arthritis. The patients have also experienced shoulder joint replacement surgery in the past that failed.
The reason for the recall is that the devices are fracturing. Such fractures can result in additional surgery that can cause "serious adverse health consequences such as permanent loss of shoulder function, infection or rarely, death."
Notices were sent to customers (health care providers) asking that any of the devices in stock be quarantined. While there are no specific instructions for monitoring patients who are affected by this recall, it is recommended that existing surgical follow-ups continue. Additional information about the recall is available at zimmerbiomet.com.
When a medical device can cause serous injury or death and is recalled, the FDA publishes the recall information on their website as well. If a patient is adversely affected by the medical device, a report can be filed with MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
If you have been negatively affected by a recalled medical device, you may be able to seek compensation for your medical expenses, pain and suffering, lost wages and more. An attorney can provide more information about your legal options.
Source: Food and Drug Administration, "Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate," accessed Feb. 24, 2017