The FDA has provided additional information to patients and medical providers regarding the recall of the Comprehensive Reverse Shoulder Implant initiated by Zimmer Biomet on December 20, 2016. The recall has been designated a “Class 1” recall, which reflects the highest classification available to the FDA. Class 1 recalls are reserved for those products where there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.
The FDA announced a recall for the shoulder implants last month, indicating that approximately 3,662 components distributed since October 2008 have shown to have higher-than-expected fracture rates. Since many of these components may have been used during shoulder replacement surgery in recent years, it is likely that implants will continue to fracture and fail the longer they remain in individual’s shoulders.
The recalled implants are used to help restore arm movement among individuals with torn rotator cuffs, severe shoulder arthritis known as arthropathy, and patients who had previous shoulder joint replacements that failed.
The trademark name of the device is the Biomet Comprehensive Reverse Shoulder Humeral. The company initiated the recall of 3,662 devices back in December. It issued an order to quarantine and remove from stock all of the affected devices from the system.
At this time, it does not appear that the manufacturer has taken any steps to make sure individuals who received an unreasonably dangerous and defective component are aware that they may face an increased risk of problems. The FDA statement noted that there are currently “no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.”
The Zimmer Biomet device being recalled was manufactured from August 25, 2008 to September, 2011. A full list of lot numbers is available on the FDA Recall notice. Patients who currently have a Biomet Comprehensive Reverse Shoulder Humeral implant will need a new surgery to deal with the defective device.
As individuals learn about the recall, or seek medical attention for problems with their Biomet shoulder, it is expected that a growing number of product liability lawsuits will be filed against the manufacturer. If you believe you may have one of the affected devices, you should promptly consult your physician for an evaluation.
As a partner with D'Arcy Johnson Day, Andrew D'Arcy has been involved in some of the nation’s most high-profile cases and investigations. His practice includes serious automobile accidents, medical malpractice, wrongful death and product defect cases. Andrew has been personally responsible for numerous multi-million dollar settlements and verdicts on behalf of his clients. He has been recognized by his peers as an "AV" rated attorney, the highest possible rating given by Martindale-Hubbell publication. Andrew has been named a "Super Lawyer" by New Jersey Monthly magazine each year consistently since 2013.