FDA Labels Spinal Fusion Medical Device Recall Class I

FDA Labels Spinal Fusion Medical Device Recall Class I

A Class I recall by the U.S.  Food and Drug Administration (FDA) is the most significant classification, indicating a higher risk of serious injuries or death than any other.  In May 2017, the FDA labeled…

A Class I recall by the U.S.  Food and Drug Administration (FDA) is the most significant classification, indicating a higher risk of serious injuries or death than any other.  In May 2017, the FDA labeled a spinal fusion medical device recall a Class I, urging healthcare providers and patients to be cautious of this potentially dangerous medical device.

Learn more about the recall, potential adverse side effects, and your legal rights in this article.  If you have questions about medical malpractice or negligence, or defective medical products, contact the medical malpractice attorneys at MedMalFirm.com to learn more.

Spinal Fusion Stimulator Recall Information

The recall includes spinal fusion stimulators manufactured by Zimmer Biomet, including the SpF PLUS-Mini and SpF XL llb Implantable Spinal Fusion Stimulators.  The devices were manufactured between October 2016 and July 2017, and were distributed between March and April 2017.  In total, 33 stimulators were included in the recall.

According to the FDA recall report, the recalled devices contain potentially harmful chemicals at higher levels than are allowed.  Exposure to these chemicals could be toxic to organs and tissue, which is called cytotoxicity.  It should be noted that not all Zimmer Biomet Spinal Fusion Stimulators are included in the recall, only select models and manufacturing dates.  Consumers with questions about specific models included in the recall should contact Zimmer Biomet.

Manufacturers like Zimmer Biomet are required to test their products for cytotoxicity to ensure that the device is compatible with the human body and falls within acceptable chemical levels.  When the medical device fails cytotoxicity tests, it indicates the potential for adverse side effects in the patient.  Potential side effects of medical devices implanted in the body include:

  • Chronic infections
  • Long-term hospitalizations
  • Additional surgical procedures
  • Paralysis
  • Death

These potential side effects are only a few of those listed as being related to cytotoxicity.  To find out more about the potential side effects for you, contact your healthcare provider right away.  To learn more about your legal rights as a patient, contact the medical malpractice attorneys at MedMalFirm.com.

Implantable Medical Device Recall Safety Information

A recall of an implantable medical device is a bit different than something that is designed to be used outside the body.  For one thing, the potential side effects are much different, and are much more likely to cause serious or permanent damage.  Another significant concern with implantable products is the fact that recalls occur after the product has been installed, and there is no “easy” option to remove the potential danger.  In the case of the Zimmer Biomet spinal stimulators, the FDA is encouraging surgeons to monitor their patients for three to six months after implantation with the recalled devices in the event that adverse side effects present.

Patients who have the recalled product already installed should be mindful of the potential dangers and seek medical attention at the first sign of problems.  Patients with questions about Zimmer Biomet devices already installed should contact their healthcare provider to find out more about the potential dangers and warning signs of a problem.  Any patient who has the recalled device installed should also report any adverse side effects with the FDA’s MedWatch reporting program.

For healthcare providers, the FDA encourages quarantining all affected devices and contacting Zimmer Biomet so a representative can collect the devices and remove them.  Surgeons should not continue to install the devices while the recall is active.

Protecting Your Legal Rights as a Patient

Manufacturers of medical devices, and the healthcare providers that use them, have specific obligations to you – the patient and consumer.  Manufacturers are required to test and monitor their products for safety and effectiveness, issue recalls when necessary, and work with the FDA and healthcare organizations to ensure patient safety.  Healthcare providers, similarly, are required to comply with the accepted standards of care when providing services to you as a patient.  Part of that requirement is informing you of defective products or drugs you may have been exposed to, and monitoring you to prevent adverse side effects.

When manufacturers or healthcare providers fail to uphold their duties to you, it is not only an unfortunate experience, it is also a violation of your legal rights.  Further, it is simply unacceptable.  If you have been injured due to a defective medical device or drug, or the negligence of a healthcare provider, you may be eligible to file a medical malpractice lawsuit.  To determine what your legal options are, consult with a medical malpractice attorney you can trust to defend and represent your legal rights and best interests.

At MedMalFirm.com, we are passionate about standing up for the rights of those injured by medical malpractice or negligence.  Our attorneys have successfully managed a wide range of cases involving defective products, doctor negligence, surgical errors, or birth injuries.  Contact our office to speak with a skilled medical malpractice attorney about your case.  Fill out our online form to schedule your free consultation.

Meagan Cline

Written By Meagan Cline

Meagan Cline is a professional legal researcher and writer. She works alongside the team at MedMalFirm.com to provide readers with up-to-date information relevant to the healthcare and legal industries.

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