We want to alert anyone who has had cervical spinal fusion surgery about this Class 1 recall. Even if you’re not sure what type of device was used during surgery, you should talk to your doctor immediately.
Louisville, KY (PRWEB) November 02, 2013
Spine injury attorney Rob Shelton of the Shelton Law Group today informed consumers about the U.S. Food and Drug Administration’s recent safety alert stating that the FDA issued a Class 1 recall of the OASYS Midline Occiput Plate.
The FDA, which on Aug. 29 posted a safety alert on its website, reports that the recall was necessary due to reports of fracture of the pin that connects the implant’s tulip head to the plate body. According to the FDA, some Stryker spine patients may experience blood loss, nerve injury and may need revision surgery to replace the damaged implant.
A Class 1 recall is regarded as the most serious type of recall because there is a reasonable risk that use of the recalled device will result in serious injury or death, according to the FDA.
“We want to alert anyone who has had cervical spinal fusion surgery about this Class 1 recall,” said Shelton, whose firm represents people injured due to medical device defects and families whose loved ones died due to defective devices. “Even if you’re not sure what type of device was used during surgery, you should talk to your doctor immediately. This type of recall should never be taken lightly.”
Stryker Orthopaedics on May 30 issued an Urgent Medical Device Recall, asking medical facilities to examine their inventory and stop distributing or using the recalled lots, according to the FDA. Less than a month later, on June 20, Stryker recommended that implant surgeons should evaluate patients with an implanted OASYS Midline Plate.
The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System, which was designed to provide stabilization in the cervical spine.
The FDA encourages healthcare professionals and patents experiencing side effects of the Stryker spine implant to report problems to the agency’s MedWatch Safety Information and Adverse Event Reporting Program by completing an online form.
About Shelton Law Group
Attorney Rob Shelton, founder of the Shelton Law Group, fights to protect the rights of those injured by dangerous medical devices and defective drugs. He also represents victims of car and truck accidents, workplace injuries, nursing home abuse, and many other types of personal injuries. Voted as one of Kentucky’s top 10 lawyers by the Kentucky Trial Court Review since 1998, Shelton is a lifetime member of the Multi-Million Dollar Advocates Forum, a distinction reserved for a small percentage of trial lawyers nationwide who have obtained verdicts or settlements for clients totaling $2 million or more.
If you have questions about Stryker spine implant and your legal rights, call 888-761-7204 for a free case evaluation.
The Shelton Law Group
9300 Shelbyville Road, Ste. 215
Louisville, KY 40202