Regulators have issued a top-level recall over Zimmer Biomet SpF spinal fusion stimulators amidst concerns that the medical devices contain chemicals that can seriously harm patients, and even be fatal.<\/p>\n
This is a serious recall<\/strong> given there is a reasonable probability that using a certain defective product can serious injure or kill the patient. It’s reported that 33 affected units were manufactured and distributed.<\/p>\n The affected stimulators are the SpF-XL IIB<\/em> (22 units) and the SpF- Plus<\/em> (11 units) Marketed as “innovation that stands the test of time” by Zimmer, the spinal fusion stimulators were created to help two or more spinal bones to reconnect permanently. The stimulant is injected into the spine for contrast electrical stimulation during surgery. According to Zimmer, the medical devices have been implanted over 100,000 times as proof of its successful clinical history. Unfortunately, the 33 affected units could result in serious injury or even death for patients.<\/p>\n Manufacturer Zimmer Biomet said that the problem was identified during routine checks on the medical device. Cytotoxicity tests are carried out to check whether a device is compatible with the human body. They believe the adverse health consequences can include:<\/p>\n
\n
\nThe devices were manufactured between 11th<\/sup> October 2016 and 18th<\/sup> January 2017, and distributed between 28th<\/sup> March 2017 and 6th<\/sup> April 2017.<\/p>\nPatients could be at risk of harm<\/h2>\n