The United States Food and Drug Administration (FDA) recently announced a Class I Recall of Comprehensive Reverse Shoulder due to the fact that these devices reportedly fracture at a much higher rate than warned on the label. Zimmer Biomet, the company that manufactures these devices announced the recall on February 16 after sending an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to customers affected by this issue on December 20, 2016.
If you were seriously injured by this faulty device, call us at (713) 909-7910Â to discuss your case with a member of our firm.
In the notice, Zimmer Biomet requested that their customers:
- Inform relevant staff members of the notice and ensure that they read it.
- Find and quarantine any of these devices that they may have in stock so that a Zimmer Biomet representative can come by and remove any devices.
- Fill out and send the Certificate of Acknowledgement form to the listed representative within three days.
- Keep a copy of the form to keep for personal records in case of an audit.
What’s Wrong With The Devices?
According to Zimmer Biomet and the FDA, these devices can cause serious injuries in case of fracture that may require revision surgery to address. Some of the health issues include:
- Infection
- Permanent loss of shoulder function
- Death
What Are These Devices Used For?
The Comprehensive Reverse Shoulder is a device that can be surgically implanted in patients to help restore arm movement. It is commonly used on patients with torn rotator cuffs whose previous shoulder replacement surgeries failed and on patients who suffer from arthropathy, a severe kind of shoulder arthritis.
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Hire An Attorney Today
If you were seriously injured by one of these faulty devices, you may be able to file a lawsuit in order to secure the compensation you need to cover any medical bills or damages you may have incurred. Our Houston personal injury attorneys at Bailey Cowan Heckaman PLLC have dedicated their careers to providing injured victims with the experienced legal representation they require. Call us at (713) 909-7910Â to speak with a member of our firm, or fill out our online form to request a free case evaluation today.
