Recently, in the April of 2017, Zimmer Biomet recalls Implantable Spinal Fusion Stimulators due to potential of harmful chemical which may be toxic to the tissues and organs. FDA has classified this recall as a Class I recall, most serious type of recall. Class I recall may lead serious injuries or death. The Spinal Fusion Stimulators are used during the spine surgery to permanently connect two or more bones together. As part of the routine monitoring, Zimmer Biomet has found in their procedure that higher levels of harmful chemical are allowed which may be toxic to the organs and tissue. This is clearly the company’s fault as not enough tests were done to assure the levels of chemicals present in the Stimulators. For example, cytotoxicity test, which can help identify the levels of chemical present in the medical device. During the approval from the FDA, they might have done testing, but may not be regularly monitoring or performing the tests on every lot manufactured.

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm561004.htm