Stryker is recalling its Tritanium posterior lumbar cage intervertebral body fusion implant. The company issued a Class 2 Device Recall at the end of November 2018.
The product, which originally received US FDA clearance in November 2015, is intended for an open, less invasive, and minimally invasive posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) surgical procedure.
Stryker sent an urgent medical device correction letter to customers on 28 November, at which time 28,461 units of the product in commerce.
According to the company, “The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intraoperatively and postoperatively.”