FDA News

Zimmer Biomet recalls implantable spinal fusion stimulators

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

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