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

$230,000

Settlement For Accident

Accidents happen quickly and without warning. Our client was stopped at an intersection behind a large truck and suffered injury requiring spinal surgery when the truck backed into her vehicle. A lawsuit was filed against the driver and the company… read more?
$840,000

Rehab Facility Death from Neglect

Settlement for resident of rehab facility caused death from malnutrition and infections from pressure sores due to neglect.
$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.
$100,000

Settlement Obtained for Client in a Head-On Crash

We obtained a $100,000 settlement for a client who was hit head on by an uninsured driver. She went to the hospital where she was treated for a concussion and bruising as well as hip,… read more?
$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.
$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.

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

What Happens Next?

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Submit Your
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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

About The Ruth Law Team

For over 40 years, The Ruth Law Team has been helping those who were injured due to an accident, defective product, nursing home abuse, and more. If you or someone you love was wrongfully hurt, The Ruth Law Team will guide and support you through the legal process.

Our team of passionate and experienced personal injury attorneys will fight for what you deserve. If you would like to speak with one of our attorneys and have your case evaluated, please don’t hesitate to give us a call at (888) 783-8378. Our lines are open 24/7.

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