FDA Recalls Stryker Spine OASYS Midline Occiput Plate

The United States Food & Drug Administration (FDA) has issued a Class 1 Recall on the Stryker Spine OASYS Midline Occiput Plate, used as an implant in spinal surgeries.  The recall was issued as a result of reported fractures of the pin that connects the implant’s tulip head to the plate body.   On May 30, 2013, Stryker, the maker of the implant, had issued an Urgent Medical Device Recall requesting medical facilities to immediately stop using or distributing recalled lots.  In June of 2013, Stryker notified spinal implant surgeons to begin routine clinical and radiographic post-operative evaluation for patients with an implant.

The FDA recommends an urgent evaluation if a patient with an implant begins to experience pain, weakness or numbness.   After revision, Stryker recommends routine post-operative care and follow-up.

Stryker has learned that in cases where a post-operative fracture occurs in the pin that connects the tulip head to the plate body, serious side-effects can occur, including blood loss, nerve injury and the necessity of a revision surgery to attempt to replace a fractured implant.  Affected products were distributed between April 23, 2010 and February 12, 2013 and include an estimated 1,536 units in the United States and another 880 abroad.