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Troubled Hip Implant Maker Faces Class I Spine Plate Recall

Posted on in FDA

The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Stryker Spine OASYS Midline Occiput Plate. The device is used as an implant in spinal surgeries. The products affected were distributed between April 23, 2010 and February 12, 2013. The plate is designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine.

In May, Stryker had issued an Urgent Medical Device Recall requesting physicians and hospitals to immediately stop using or distributing the product because of reports they had received of fractures of the pin that connects the implant's tulip head to the plate body. In June the company notified surgeons to perform routine clinical and radiographic evaluations for patients who have the implants.

If post-operative fracture occurs in the plate pin, serious side-effects can occur, including blood loss, nerve injury and the necessity of a revision surgery to attempt to replace a fractured implant. The FDA is warning physicians to watch for patients who may be experiencing pain, weakness, or numbness as symptoms of a pin fracture.

Stryker has not released how many implants are affected by the recall or what the anticipated costs will be.

The company has had issues with other defective problems in the past. Last year, there were recalls issued for the Rejuvenate and ABG II hip implants. Stryker has already paid pay more than $400 million to cover lawsuits and revision surgeries, with many more still pending.

If you have had issues with a Stryker spine plate, or any other defective medical device, contact an experienced Illinois attorney to find out what compensation you may be entitled to for pain and loss.

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