The FDA has identified the Zimmer Biomet recall as a Class I recall. It’s the most serious type of recall and means there is a risk of serious injury or death.
Attorney Dr. Shezad Malik, who is also a medical doctor says, “This notice should be taken very seriously.
“If someone has had a shoulder replacement they should immediately check with their physician to see if they had the affected model implanted.
“The patient may also receive a recall letter from Zimmer-Biomet or get a follow-up letter from their doctor.”
The Comprehensive Reverse Shoulder System Humeral Tray Model 115340 was designed to be surgically implanted in patients with rotator cuff tears who developed a severe type of shoulder arthritis known as arthropathy. It was also used as a replacement for previously failed shoulder joint implants.
“If the device failed patients would notice significant shoulder pain, a loss of function of their shoulder and arm, or experience a sudden fracture that would be obvious and dramatic. There is also a risk of infection developing,” says Dr. Malik. “This is a serious issue.”
The trademark name of the device is the Biomet Comprehensive Reverse Shoulder Humeral. The company initiated the recall of 3,662 devices December 20, 2016. It issued an order to quarantine and remove from stock all of the affected devices from the system.
The Zimmer Biomet device being recalled was manufactured from August 25, 2008 to September, 2011. A full list of lot numbers is available on the FDA Recall notice.
The Comprehensive Reverse Shoulder was introduced for use under the FDA's 510(K) program. Manufacturers may skip human clinical trials of a device if the manufacturer can show that device or product is “substantially equivalent” to a similar product or device that the FDA approved previously.
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Patients who currently have a Biomet Comprehensive Reverse Shoulder Humeral implant will need a new surgery to deal with the defective device.
“This would likely require a full shoulder implant removal and replacement with another type of device in severe cases,” says Dr. Malik. “In some cases it might mean partial replacement.”
People who have had implants may qualify for compensation from Zimmer Biomet for pain and suffering.
“We are beginning to receive calls in my law office from people,” says Dr. Malik. “Most people do not know which make and model of implant they have. However this is very easy to find out. They can check with their doctor. They always know which devices have been used.”