FDA Announces Recall for Zimmer Biomet Comprehensive Reverse Shoulder Implant Due to High Fracture Rate
The FDA announced a Class I Recall of the Comprehensive Reverse Shoulder Humeral Tray (Model 115340) because the devices are fracturing at a higher rate than stated in the labeling. The Zimmer Biomet Comprehensive Reverse Shoulder medical device was recalled by the FDA on February 15, 2017. Fractures may require should revision surgeries which can cause serious adverse health conditions.
Biomet Comprehensive Shoulder Implant Complications
Over 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain and
restore arm movement. There are several types of shoulder replacement surgeries, including conventional and reverse shoulder replacement.
Reverse shoulder replacement is traditionally performed in patients who have completely torn rotator cuffs or previously failed shoulder surgeries. Reverse implants rely on different muscles to move the arm than traditional implants and can help restore some motion in the patients shoulder area.
The Comprehensive Reverse Shoulder System by Zimmer Biomet has been blamed for painful complications, including:
- bone loss
- device fracture
- device failure
- repositioning / malpositioning
- need for additional surgeries
Have You Had Shoulder Replacement Surgery?
The Olinde Firm is currently reviewing potential product liability /medical device lawsuits for individuals who have failed Biomet Reverse Shoulder Implants or have experienced medical problems due to the Biomet Comprehensive Shoulder implant. Compensation may be available to those who qualify.
Filing a Shoulder Replacement Lawsuit May Help
Individuals who underwent revision surgery following fracture or replacement of a Zimmer Biomet Comprehensive Reverse Shoulder may be entitled to compensation for medical bills, lost wages, pain and suffering, and more. To learn more about filing a Zimmer Biomet shoulder replacement lawsuit, please contact The Olinde Firm at 1-800-587-1889 for your free case review.
Comprehensive Reverse Shoulder System is a registered trademark of Zimmer Biomet.
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If You Had a Shoulder Joint Replacement that Failed, Forcing You to Undergo Revision Surgery, You May Be Eligible for Compensation. Contact Us For A FREE CONSULTATION.
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