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

$350,000

Driver Sideswiped by Commercial Vehicle

Settlement for driver sideswiped by a commercial vehicle. The victim suffered neck and low back injury resulting in lumbar laminectomy. The driver also suffered from depression and anxiety which was aggravated by this collision.

$275,000

Vehicle Struck by Commercial Truck

Amount recovered for car accident victim who was severely injured when her vehicle was hit by a commercial truck that crossed over into her lane. She experienced permanent neck, jaw and shoulder injuries and had to undergo surgery on her neck.

$650,000

Victim Dies from Sealant Fumes

Settlement for the family of a victim who died after inhaling fumes from a sealant product produced and sold nationally. The product is known to cause serious injury and death but no warnings and no recall was issued.

$150,000

Client Injured at Car Wash

Our client was at a car wash drying her vehicle when she stepped into a gaping hole in the pavement, causing her to call. She suffered a broken coccyx and broken ribs, ultimately resulting in a $150,000 settlement.

$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.

$360,000

Drug Causes Severe Kidney & Muscle Damage

Settlement for victim who took drug for several weeks and suffered severe kidney and muscle damage. The drug was ultimately recalled.

$200,000

Settlement for Bicyclist

$200,000 settlement for a gentleman who was bicycling on a city street and caught his hand/handlebar on a utility wire, causing him to sustain multiple fractures when he flipped over his bicycle.

$60,000

Driver Fractures Arm in Auto Accident

Recovery for driver who fractured her arm in a car accident while she was visiting family in Florida from out of state.

$275,000

Driver Rear Ended While Stopped in Traffic

Verdict of $275K obtained for a driver rear ended at high rate of speed while stopped in traffic for a school bus. Our client sustained significant injury to his knee, resulting in surgery as well as injuries to his neck and a concussion.

$22,000

Settlement For Car Passenger Injured

$22,000 settlement for a passenger in a car hit during a left hand turn.

$105,000

Bicyclist Hit by a Van

Our client was visiting from out of state when his life was changed in an instant. This gentleman was riding his bicycle when a van voided his right-of-way and turned left in front of him in Seminole, Florida. This case settled out of court.

$100,000

Rear-End Collision Verdict

Verdict to a resolve a claim arising from a rear end collision.

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:

Complete Our Case Evaluation Form

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Speak with One of Our Attorneys

The best way for you to have a clear idea your options is to speak with an attorney who specializes in your area of need.

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