FDA: Class I recall of Zimmer Biomet Comprehensive Reverse Shoulder

Editor's Note

The Food and Drug Administration (FDA) has categorized the recall by Zimmer Biomet (Warsaw, Indiana) of its Comprehensive Reverse Shoulder as Class I, the most serious.

The recall was issued because the devices are fracturing at a higher rate than is stated in the labeling.

Fractures may result in revision surgeries, which could result in serious adverse consequences such as permanent loss of shoulder function, infection, or death.

Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.