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Rick Shapiro
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FDA: Shoulder Implant Device Recalled Due to Fracture Risk

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ucm541881Over the past several years, there have been multiple recalls involving implant devices because of the dangerous risks they pose to patients. These recalls have included devices use for hip replacement and for knee replacements. Recently, the Food and Drug Administration announced a new recall — this time for shoulder implant devices.

Zimmer Biomet Comprehensive Reverse Shoulder

The company that makes the device — Zimmer Biomet — is recalling 3662 of their comprehensive shoulders. These devices are primarily used on people who have suffered rotator cuff tears and who have not found relief with past shoulder joint surgery. The device aids in helping to restore movement of the shoulder, which is often lost because of the injury.

It was recently discovered that these particular devices have a higher fracture rate than the company’s warnings indicate. If the device fractures, more surgery becomes necessary, leaving the patient susceptible to infections risks or a permanent loss of shoulder function. In some cases, the adverse effects can be fatal.

Class 1 Recall

The FDA has labeled this recall a Class 1, which is the most serious class of recall that can be issued. Class 1 recalls require companies to send out their recall notices with the words “URGENT Medical Device Recall” in red bold type on both the envelope and the notice itself. Federal regulations require that all patients, contractors, and distributors be notified. Zimmer Bioment sent notices out December 20, 2016. Affected parties can find the model and lot numbers of the recalled devices on the FDA website.

The advice from the company is that devices should be removed from the medical facility inventory and will be picked by a Zimmer Biomet representative. However, there is no advice for patients who have already had the devices implanted in their shoulders. If the device should fracture and the patient has to undergo surgery, the regular surgical protocols should be followed, according to the recall notice.

Contact a Defective Product Attorney

If you have suffered injuries or adverse side-effects from a defective product, faulty medical device, or a dangerous recalled medication, contact a seasoned Virginia personal injury attorney to find out what recourse you may have against the manufacturer. These dangerous products can leave victims with permanent and debilitating injuries and victims may be able to collect damages.