The Zimmer Biomet Comprehensive Reverse Shoulder was approved in 2008 under a process called 510(k), which indicates the device is equivalent to another shoulder replacement already on the market. Additionally, this “fast track” approval process indicates the product is at least as safe and effective as a device being legally marketed. The Comprehensive Reverse Shoulder replacement was created to help restore arm movement after an injury such as a rotator cuff tear, a problem such as shoulder arthritis, or after a previous shoulder replacement failure.

The Food and Drug Administration (FDA) issued a Class I recall for the Zimmer Biomet Shoulder Replacement device, which is the most serious type of recall. According to the FDA, a Class I recall indicates “there is a reasonable probability that the use of, or exposure to, a violative product (in this case the Zimmer Biomet Shoulder) will cause serious adverse health consequences or death.” If you’ve had a fracture, a revision surgery may be necessary and could result in loss of shoulder function, infection and in some rare cases, even death. The recalled product was distributed between October 2008 and September 2015.

On December 20, 2016, healthcare professionals with the affected product were sent an Urgent Medical Device Recall Notice and Certificate of Acknowledgement form. The notice requested that customers:

  1. Review the safety notice and notify staff
  2. Identify affected devices in stock
  3. Have a Zimmer Biomet sales representative remove the devices from the facility
  4. Fill out and return the Certificate of Acknowledgement within 3 days and keep a copy for records

The Ruth Law Team handles many types of medical device and product liability claims. If you’ve had a fracture after a Zimmer Biomet Shoulder replacement, call us for a free case evaluation at (888) 783-8378. For more than 40 years, we’ve helped personal injury victims who have been hurt in accidents or by defective medical devices such as this one. As always, there are no fees or costs unless make a financial recovery on your behalf.

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Recalled Product Information:

Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Product Code: KWS, PAO
Lot Numbers: All lots with part number 115340
Manufacturing Dates: August 25, 2008 to September 27, 2011
Distribution Dates: October 2008 to September 2015
Number of Zimmer Biomet Comprehensive shoulder devices recalled: 3,662

Our Case Results

$75,000

Rollover Accident

A negligent driver turned left in front of our client, causing our client’s SUV to flip over.  EMS transported our client to the hospital.  The rollover crash resulted in neck, head, and shoulder injuries.

$14,300,000

Verdict to Parents for Wrongful Death of Son

We fought for parents of a car crash victim with a jury verdict for wrongful death of their son.

$292,500

Hospital Patient Develops Bedsores

Settlement recovery for hospital victim who developed bedsores on his back while a patient in the hospital.

$135,000

Trip and Fall at Wholesale Club

Our premise liability team was able to secure $135,000 for a client who tripped and fell over a rug at a popular wholesale club.

$950,000

Verdict for Passenger Injured in Head-On Collision

$950,000 in head on collision. The victim was a passenger and sustained multiple fractures, collapsed lung, and lacerated spleen.

$262,500

Victim Suffers Infection After Hip Replacement

Settlement obtained for victim admitted to the hospital following infection in recently replaced hip. While in the hospital he was not appropriately turned and re-positioned and he developed a large bedsore on his back which reached down to the bone.

$63,000,000

Verdict For Family Of Man Killed By A Negligent Driver

A 27 year old male was tragically killed on his motorcycle while riding on Martin Luther King Jr Boulevard in south St. Petersburg, FL. A graduate of the United States Military Academy at WestPoint and a professional athlete with a promising career, his life was cut short due to a negligent driver. Our experienced trial attorneys were con... read more?

$262,500

Hospital Patient Suffers Infection After Hip Replacement

Settlement obtained for victim admitted to the hospital following infection in recently replaced hip. While in the hospital he was not appropriately turned and re-positioned and he developed a large bedsore on his back which reached down to the bone.

$250,000

Head-On Collision with Commercial Truck

Settlement for victim injured when hit head on by commercial truck. She experienced significant injuries including compound fracture of tibia and fibula that broke through the skin requiring surgical repair.

$250,000

Nursing Home Resident Abused & Neglected

Recovered for victim of sustained multiple falls, fractured arm, infections, bedsores on back and heels, and became malnourished and dehydrated.

$100,000

Brain Injuries After Bike Accident

The insurance company tendered the policy limits for a client who survived multiple fractures and brain injuries and after a bike accident in Tarpon Springs.

$2,000,000

Car Accident Settlement

Settlement for a woman who was severely injured in a crash caused by a distracted driver. Our client suffered lifelong injuries including a traumatic brain injury and pelvic fractures and has spent a considerable amount of time in a rehabilitation center.

NOTE: Client may not obtain the same or similar results.

What Happens Next?

At The Ruth Law Team, we understand that this may be your first time seeking legal counsel and how intimidating that decision might be. This is why we have simplified the process to help you make the right decision for your circumstances. This 3-step process includes:

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Submit Your
Claim

Once you decide that The Ruth Law Team is the right option to represent you, we will begin the process of submitting your claim.

Contact Our Attorneys

It is essential to hold any involved parties accountable for the damages that they have caused by contacting The Ruth Law Team at (888) 783-8378 for a free review of your case by one of our lawyers. Let us put our experience and resources to work for you so you can focus on putting your life back together.

Steven and Jenna Ruth Evaluating a Personal Injury Case