Zimmer Biomet spinal fusion recall
On May 31, the Food and Drug Administration announced the immediate recall of the Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators. The FDA found that these devices release into the body higher-than-allowed levels of potentially harmful chemicals that may be toxic to tissues and organs.
The Zimmer Biomet Spinal Fusion Stimulators are implanted into patients’ backs, where they provide constant electrical stimulation to surgical sites for the purpose of reducing pain. The devices were manufactured between October 11, 2016, and January 18, 2017, and were distributed between March 28, 2017, and April 6, 2017.
The FDA recalled these devices because the chemicals they may release may cause serious, adverse health consequences, including but not limited to chronic infections, long-term hospitalizations due to additional surgical procedures, paralysis, and death.
Those affected by the recall include health care providers who used the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators, and all patients who have undergone or are undergoing spinal fusion procedures involving these devices.
On April 20, Zimmer Biomet sent an Urgent Medical Device Removal notification to all affected customers. If you have questions related to this recall, Zimmer Biomet may be contacted at 1-800-447-3625, or zimmerbiomet.com.
Consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
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