Stryker initiated a recall of its Oasys Occipito-Cervico-Thoracic System. FDA regulators assigned the recall Class I status, indicating a serious risk of patient injury or death.

The Oasys Occipito-Cervico-Thoracic System is designed to stabilize the junction between a patient's vertebrae and occipital bone. Both of these anatomical features are found in the cervical spine. The company received reports that the pin that links the plate body and the tulip head can fracture under some conditions. This can lead to nerve injury or blood loss. In some cases, revision surgery may be needed to correct the fracture.

The company first initiated a recall of the device in May of this year. At that time, Stryker warned customers to stop using impacted lots. The company requested that all impacted lots be shipped back to the company for replacement. Two months ago, the company sent out another notice warning surgeons to conduct post-op evaluations for patients who received the implants.

In its latest notice, the company provided further detail on the recall timeline. However, Stryker has not yet stated the total number of impacted devices. The company has also declined to share the impact of the recall on its bottom line.

Stryker has a colorful history of recall costs associated with implants. Last year, the company recalled its ABG II and Rejuvenate hip implants. In total, the company paid out $400 million revision surgeries and lawsuits for the devices. This is $10 million more than the company predicted in January. That being said, the company has managed profit gains for the last three quarters.