Zimmer Biomet has begun the process of recalling its SpF Plus-Mini and SpF XL IIb implantable spinal fusion stimulators in the USA, “due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs,” a US Food and Drug Administration (FDA) MedWatch Safety Alert notes.
The high levels of these chemicals were discovered during routine monitoring.
“The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalisation due to additional surgical procedures, paralysis, and death,” the Safety Alert says.
All affected batches of the products should now be quarantined before removal by Zimmer Biomet staff.
The implantable devices are designed to increase the possibility of fusion during spinal surgery by delivering “constant electrical stimulation” to the site of surgery.