Stryker Implant Attorneys Orlando
For more than seven decades, Stryker has been one of the world's leading producers of innovative orthopedic technologies and medical devices, such as implants for hip and knee replacements. However, since 2007, the U.S. Food and Drug Administration has been closely scrutinizing the company's implantable products as well as their manufacturing and marketing processes. Although none of the issues resulted in a mandated FDA recall, the company did receive numerous FDA warnings and consumer safety alerts.
In 2012, Stryker announced a Voluntary Recall of two artificial hip implants. Following post-market surveillance that confirmed fretting and corrosion problems with the metal-on-metal hip implants, distribution was terminated for both the Rejuvenate and ABG II modular-neck models. A couple of months later, the company issued a Class 1 Recall for their high vacuum/high flow waste management system used in many post-surgical environments.
Under pressure from the FDA, on April 10, 2013, Stryker issued an Urgent Medical Device Recall of its single-use cutting guides used by surgeons to interoperatively position the Triathlon Knee System* during total knee replacement surgery. According to the manufacturer, a software defect with the alignment device may have caused missed cuts resulting in:
- Joint instability
- Fractures to leg bones
- Chronic pain
- Limited joint mobility
- Need for revision knee implant surgery
*NOTE: The Class 1 Recall applies to Stryker ShapeMatch Cutting Guides and does not affect the Triathlon Knee System or Triathlon standard instrumentation.
Class 1 Recalls are the most serious type of medical recalls and are only issued when there is a reasonable probability that the use of a product has or will cause serious adverse consequences or death. If you are a Stryker patient who is symptom-free, you should continue to follow-up with your surgeon or physician as prescribed. Patients who are uncertain if they have had one of the recalled Stryker products used during surgery should contact their physician to consult their medical records. If you or a loved one received personal injuries or financial damages due to a Stryker failed orthopedic device or surgical equipment, you should seek legal counsel immediately.