Stryker, a well known artificial hip and medical device manufacturer, is recalling devices used in spinal surgeries. The FDA has assigned its most serious warning label to the problem, indicating that using the device could result in serious injury or death. Stryker is already under fire over lawsuits involving its Stryker Rejuvenate and ABG II artificial hips, amid allegations of early failure of the devices and the risk of metallosis. Metallosis occurs when the component parts grind against each other releasing metal ions into the bloodstream and hip joint, leading to loosening of the hip device, bone destruction, pain and swelling.
Stryker has received reports that a pin that connects the tulip head to the plate body can fracture, possibly causing blood loss, nerve injury and the need for revision surgery. The FDA put its Class I designation on the recall, a notification for potentially deadly malfunctions.
Stryker Recall 2013
Stryker initiated the recall in May, warning hospitals and doctors to stop using the affected lots and ship them back to the company. In June, Stryker put out a release warning surgeons to conduct routine post-op evaluations on patients who already have Oasys implants, and to monitor for symptoms that may require revision procedures.
FDA Stryker Class 1 Recall
The affected products were distributed from April 23, 2010, through February 12, 2013.
Product Codes and Lot Numbers: KWP; all lots
Manufacturing Part Number Product Description
48551044 OASYS MIDLINE OCCIPUT PLATE, SMALL
48551045 OASYS MIDLINE OCCIPUT PLATE, MEDIUM
48551046 OASYS MIDLINE OCCIPUT PLATE, LARGE
48551047 OASYS MIDLINE OCCIPUT PLATE, LARGE LONG
48551048 OASYS MIDLINE OCCIPUT PLATE, MINI
Use: The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
On May 30, 2013, 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 medical facility has the affected product in stock, it should be returned to Stryker.
On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate. If a patient begins experiencing symptoms including pain, weakness, or numbness, more urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.