FDA Announces Stryker Spinal Plate Recall

The U.S. Food and Drug Administration (FDA) has announced the recall of the Stryker Spine OASYS Midline Occiput Plate over a potentially dangerous side effect, signaling that there is a “reasonable possibility” that the product could lead to “serious adverse health consequences or death.”

The FDA issued a Class 1 recall against the plate, which is reported to have been distributed between April 23, 2010 and February 12, 2013. The agency estimated 1,536 units exist in the U.S. and another 880 internationally.

The plate is used as part of an implant in spinal surgeries, and fractures in the pin that connect the implant head to the plate body have been reported recently.

This is not the first time Stryker has come under fire and faced a recall because of allegedly defective products. In 2009, the company’s Rejuvenate and ABG II modular-neck hip stems were recalled due to corrosion at the modular neck junctions.

There is also ongoing litigation over Stryker hip implant side effects, which have been linked to failing prematurely, corroding or shredding into metal fragments, which can lead to metallosis (metal poisoning).

Alleged defective medical device manufacturers like Stryker must be held liable if their products injure people. The MDL attorneys at ZK are involved in litigation regarding these defective implants, as well as other dangerous medical and consumer device litigations.

The FDA reported that Stryker “issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots.”

If a defective Stryker implant has injured you, contact our firm today. Our experienced lawyers can investigate the negative side effects of any claim you may have. Our firm offers confidential, no obligation consultations.