The Zimmer Biomet Comprehensive Reverse Shoulder replacement has been recalled after reports indicate it proposes a higher risk for fracture than initially stated. A total of 3,662 people with these shoulder replacement devices are affected by the recall.
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:
- Review the safety notice and notify staff
- Identify affected devices in stock
- Have a Zimmer Biomet sales representative remove the devices from the facility
- Fill out and return the Certificate of Acknowledgement within 3 days and keep a copy for records
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, 211
Distribution Dates: October 2008 to September 2015
Number of Zimmer Biomet Comprehensive shoulder devices recalled: 3,662
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 1-888-783-8378. For more than 35 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.