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Zimmer Biomet Shoulder Recall: What You Need to Know

Shoulder replacement devices manufactured by Zimmer Biomet, the second largest medical device maker in the world, have come under scrutiny for subjecting patients to risks of serious injury and even death. In February of 2017, the FDA announced that the recall of Zimmer Biomet Comprehensive Reverse Shoulder implants would be labeled as a Class 1. Class 1 recalls are the most serious classification reserved for products that pose a “reasonable probability” of causing harm.

The Zimmer Biomet shoulder recall affects devices manufactured between August 2008 and September 2011, and distributed to health care providers between October 2008 and September 2015. Patients who have undergone shoulder implant and replacement surgery using a Zimmer Biomet device between 2008 and December 2016 may have received a recalled device.

The recall stems from a number of adverse event reports in which it was discovered that the device was prone to fracture at higher rates than anticipated, something that was not stated on the product’s label. Fractures can cause the shoulder device to break, as well as shoulder separation, severe pain, loss of shoulder mobility, revision or replacement surgery, infections, and even death.

Part of the reason behind the device’s increased risks of fractures and patient harm stem from the fact that it was cleared by the FDA using the expedited 510(K) process. This expedited process allows certain medical devices to become available to the public without standard safety testing, as long as the manufactures can show that the new medical device is similar to one that has already been approved.

After receiving patient reports of adverse events, Zimmer Biomet issued a recall of the device in December 2016. Because the device manufacturer only alerted physicians and hospitals, however, many patients with the device already implanted may not have been made aware of the recall and potential dangers. It was also discovered that Zimmer Biomet knew of fracture risks associated with its shoulder device as early as 2010, yet continued to sell the product.

Shaheen & Gordon, P.A. is currently reviewing cases from patients who received a Zimmer Biomet shoulder implant anytime between 2008 and 2016 and experienced injuries, revision surgeries, and other serious complications. We are also filing lawsuits on behalf of injured victims over the defective design, manufacturing, and marketing of the device.

Learn more about your right to financial compensation and whether you may have a case by requesting a consultation with a Maine attorney from our firm. Shaheen & Gordon, P.A. proudly serves clients throughout Maine, New Hampshire, and Northern New England. Contact us today.