A Class 1 recall has been issued for the Zimmer Biomet Comprehensive Reverse Shoulder Humeral. This is the most serious type of recall. It is only issued when the continued use of a product poses a risk of serious injury or death.
When it was developed, the shoulder implant product seemed quite promising. It offered hope to people who had suffered a rotator cuff tear, had developed a type of severe shoulder arthritis, or who had previous shoulder replacement implant that failed. So promising was the product that Zimmer Biomet gained FDA approval through the 510(K) fast-track program. This program enables medical device manufacturers to get products approved for sale without having to complete the usual round of human trials.
It looks now like Zimmer Biomet should have conducted those trials. The Comprehensive Reverse Shoulder Humeral is failing at a rate higher than was expected. And when the product fails, a patient must undergo revision surgery than increases the risk of permanent loss of shoulder function and mobility, infection, and death.
People who have received the Zimmer Biomet Comprehensive Reverse Shoulder Humeral implant may be eligible for compensation for their medical costs, pain and suffering, and other economic and noneconomic losses. They should speak with an experienced defective medical device attorney as soon as possible.