This article is more than 5 years old. Information may no longer be current.

Zimmer Biomet recalls implantable spinal fusion stimulators

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Zimmer Biomet announced a recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators, according to a release from the FDA.

The devices are used during spinal fusion surgery to decrease the possibility of permanently connecting two or more bones of the spine together. The release noted that Zimmer Biomet has found higher than allowed levels of potential harmful chemicals, which may cause cytotoxicity, during a routine monitoring procedure. According to the release, use of the product may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis and death, among other serious adverse health consequences.

Hospitals and physicians should quarantine all affected products and return the products to Zimmer Biomet. The FDA notes surgeons should perform normal clinical monitoring for 3 months to 6 months postoperatively for patients implanted with the affected devices.

Reference:

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm561004.htm