On April 20, 2017, Zimmer Biomet recalled the SpF PLUS-Mini (60μA/W) and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potentially harmful chemicals—which may be toxic to organs and tissue—that were discovered during the company’s routine monitoring protocol. The cytotoxicity tests for these products came back positive, indicating that the device contains harmful chemicals in amounts that could be harmful to the patient.
The affected serial numbers for the SpF-PLUS are 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, and 224667.
The affected serial numbers for the SpF-XL IIB are 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, and 410171.
Distribution dates for these products are March 28, 2017 to April 26, 2017. Manufacturing dates are October 11, 2016 to January 18, 2017. So far, the number of devices that have been recalled in the United States is 33.
All affected customers should have received an Urgent Medical Device Removal notification, urging them to review the letter, distribute the information to all appropriate personnel, and quarantine all affected products. Customers with questions related to this recall are instructed to contact Zimmer Biomet at 1-800-447-3625 or by email to firstname.lastname@example.org.
If you have suffered injury from this medical device in Missouri, request a free consultation with our Kansas City product liability attorneys at Bertram & Graf, L.L.C. today.