It is always the responsibility of a company to ensure the safety and efficiency of their product upon release. However, sometimes companies do not know the complete risk of a product until after it is distributed. For instance, Zimmer Biomet recalled their Comprehensive Reverse shoulder System because of its high fracture rate. The system was meant as a shoulder replacement implanted to repair arm movement. However, the product would fracture, which would then lead to surgery to correct the issue, which in turn may cause complete damage of shoulder function, infection, or even death. The distribution of the product was from 2008 to 2015. The FDA recalled the device and classified it as Class I.

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm