FDA said a shoulder replacement device recalled by Zimmer Biomet is considered a Class I recall. The device is being recalled due to a high rate of fractures.

Amanda Pedersen

Zimmer Biomet recalled its Comprehensive Reverse Shoulder device due to a high rate of fractures. FDA identified the recall Thursday as a Class I, the most serious type of recall.

A high fracture rate forced Zimmer Biomet to recall its 3,662 of its Comprehensive Reverse Shoulder devices, and FDA classified the recall Thursday as a Class I, the agency's most serious type of recall. The devices included in the recall were made between Aug. 25, 2008 and Sept. 27, 2011 and distributed between October 2008 and September 2015.

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. The device is designed for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.

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

Zimmer Biomet is investing $170 million to "harmonize and optimize" its supply chain and manufacturing and quality systems. FDA hit the company with a 57-page Form 483 in December, which was one of the longest and most serious 483s one device consultant had ever seen.

This is the six Class I recall of 2017. Other device recalls FDA has reported so far this year include: Physio-Control's Lifepak monitor/defibrillator due to an electrical problem; CareFusion's Alaris Pump Module because of a faulty Air-In-Line sensor that could generate a false alarm; Bard Peripheral Vascular's Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient's leg; bioMerieux recalled its Nuclisens reagents and accessory products due to a quality problem of the magnetic silica component; and Nurse Assist recalled its saline flush syringes due to a bacteria contamination that can cause bloodstream infections.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image credit: FDA]