Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators

By Julie A. Vetalice

Zimmer Biomet is recalling SpF® PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to potential cytotoxicity issues that were found during routine monitoring. This Class I recall affects units manufactured between 10/11/16 to 1/18/17, distributed from 3/28/17 to 4/6/17. In the U.S., 33 devices are recalled.

The implantable devices are designed for use during spinal fusion to increase the possibility of permanently connecting two or more bones of the spine.

Source: FDA.gov

Product Labels: Spinal Fusion