Stryker issued a Class 2 Device Recall of its Tritanium Posterior Lumbar cage in late 2018.
Five things to know:
1. The company initiated a recall of the Tritanium Posterior Lumbar cage for intervertebral body fusion Nov. 28. The product is designed for open as well as minimally invasive posterior lumbar interbody fusion or transforaminal lumbar interbody fusion.
2. Stryker's Howmedica Osteonics manufactures the device.
3. On the FDA's website, Stryker listed the reason for the recall as: "The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intraoperatively and postoperatively." The FDA's determined cause is still under investigation.
4. Stryker sent an urgent medical device correction letter to customers Nov. 28. At the time of the recall, there were 28,461 units of the device in commerce.
5. The Tritanium Posterior Lumbar cage originally received FDA clearance in November 2015.