Reports of dangerous complications have led the Zimmer medical device company to recall a component of its Biomet comprehensive shoulder system.

The device at issue is designed for use in so-called “reverse” shoulder replacement, in which a ball-shaped component implanted in the torso interfaces with a socket-shaped component implanted in the top of the arm bone.

It was previously authorized for retail in 2008 when it was previously marketed and advertised by Biomet. Zimmer later purchased and attained Biomet in 2015.

Patients may benefit from the Biomet comprehensive shoulder system if they have suffered from rotator cuff tears, developed an uncompromising and unyielding type of shoulder arthritis called arthroplasty, or have had prior unsuccessful shoulder joint replacement surgery.

However, part of the Biomet comprehensive shoulder system has been recalled due to a high fracture rate in the use of the medical device. The high fracture rate has been deemed to be more frequent than what was previously indicated in the stated labeling.

According to the U.S. Food and Drug Administration, or FDA, “fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”

In December 2016, Zimmer Biomet released an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement notice to consumers who may be affected by the Biomet comprehensive shoulder system.

The recall notice classified a Class I recall. According to the FDA, Class I recalls are “the most serious form of recall,” and they are “reserved for medical devices that pose a ‘reasonably probability’ of ‘serious adverse health consequences.’”

Patients who have undergone total shoulder replacements using the Biomet comprehensive shoulder device may be at risk for fractures.

The recall notice alerted surgeons and orthopedic specialists to “identify and quarantine any affected devices in stock” and that a “Zimmer Biomet representative will remove the affected device from the facility,” according to the FDA.

Zimmer Biomet is recalling roughly 3,662 devices that were manufactured between August 2008 and September 2011 and were supplied and issued between October 2008 and September 2015.

This is not the first time that a recall has been issued involving these shoulder replacement implants.

Three years later after the device’s initial introduction in 2008, Biomet released a Class II recall. It had previously also received “complaints regarding fracturing device,” and similarly to the recent Class I recall, it had detected Biomet’s humeral tray component as the issue behind the elevated frequency of “fractures and implant failures.”

One patient who allegedly suffered complications after twice receiving a Biomet comprehensive shoulder system responded with a shoulder implant lawsuit in 2014. Biomet decided to reconcile the lawsuit with a $350,000 settlement agreement.