Biomet Shoulder Recall Issued After Reverse Shoulder Replacement System Recipients Complain of Infection and Loss of Shoulder Function.
A Biomet shoulder recall was issued for over 3,600 Comprehensive Reverse Shoulder Replacement Systems. The Biomet shoulder system recall was issued after receiving continued complaints over the failure of its shoulder replacement device fracturing at a higher rate than is stated in the labeling. Men and women who have the Biomet shoulder replacement implants are at risk for infection, permanent loss of shoulder function, and even death, according to the Biomet shoulder system recall announcement. Southern Med Law has been investigating potential Biomet shoulder recall lawsuits after the U.S. Food and Drug Administration (FDA) categorized the recall as Class 1, the regulatory agency’s most serious type of recall, because the Biomet shoulder replacement device can cause severe injury and even death.
Southern Med Law has been monitoring recent developments stemming from the Biomet shoulder recall and continue to field questions from patients implanted with the Biomet shoulder replacement system.
“Men and women who have sustained loss of their shoulders function and other serious injuries because of the Biomet Comprehensive Reverse Shoulder implant, may be entitled to compensation” says Dr. Francois Blaudeau, a practicing attorney and notable doctor who heads Southern Med Law.
The law firm is currently investigating legal claims from patients who have been allegedly injured from the recalled titanium Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340. If you or a loved one have been injured by the recalled shoulder replacement device, you may be eligible to file a Biomet Shoulder recall lawsuit. To speak to one of the firm’s Biomet Shoulder Recall Lawsuit attorneys, please call 205-547-5525 or visit www.southernmedlaw.com and fill out the online form.
In December, Zimmer Biomet initiated a Biomet shoulder recall of 3,662 titanium Comprehensive Reverse Shoulder System Humeral Tray devices. All lots with part number 115340 were recalled. The Biomet shoulder recalled devices were manufactured from August 25, 2008 to September 27, 2011 and distributed between October 2008 to September 2015. Zimmer Biomet directed medical providers to identify and quarantine any affected devices in stock so that a company sales representative could remove them from the facilities. The company did not provide specific instructions for patients but recommended that they follow up with their surgeon.
[http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm]
The Biomet Comprehensive Reverse Shoulder helps restore arm movement. According to Zimmer Biomet, the replacement shoulder device is beneficial for patients with rotator cuff tears who develop arthropathy, a severe type of shoulder arthritis and for patients who had shoulder joint replacement that failed. The device received clearance from the FDA in 2008 via the 510(k) program. The FDA’s clearance program does not require medical device manufacturers to test their new products on humans if they can show their products are “substantially equivalent” to another FDA-approved device already on the market.
Zimmer Biomet began having problems with its Comprehensive Reverse Shoulder device about two years after the FDA’s clearance. In September 2010, the company recalled its Comprehensive Reverse Shoulder Humeral Tray with locking ring because of fracturing at the joint between the trunnion and the baseplate. Seven months later, the Biomet Custom Comprehensive Reverse Shoulder Humeral Trays were recalled over certain units that may contain a locking ring that was incorrectly assembled.
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A review of court records shows Zimmer Biomet has been a defendant in numerous Biomet lawsuits involving its hip and knee replacement devices. Court documents also show the company settled a Comprehensive Reverse Shoulder Replacement lawsuit last year for $350,000. According to the Biomet shoulder lawsuit complaint, a Colorado man had left and right Comprehensive Reverse Shoulder Replacements removed. The devices were part of the 2010 Biomet shoulder replacement recall. (Zimmer Biomet shoulder replacement lawsuit No. 14-2667, U.S. District Court, District of Colorado.)
About Southern Med Law And Filing A Biomet Shoulder Recall Lawsuit
Southern Med Law, led by Dr. François Blaudeau, an attorney and a practicing Doctor, has a deep understanding of the complex medical and legal questions at issue in the Biomet Reverse Shoulder Replacement recall. They are not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success. To speak to one of the firm’s Biomet Shoulder Recall Lawsuit attorneys, please call 205-547-5525 or fill out the online form.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
francois@sml-legal.i-mlaw.com
www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam
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