In a recall notice dated April 30, 2020, but published Thursday, the company said the issue was discovered during routine bacterial endotoxin testing of polyethylene implants. Three polyethylene implant samples during an approximate 6-week period were found to exceed the FDA-adopted standard for endotoxin levels of 20 EU per device. (An EU is a unit of measurement for endotoxin activity, according to the FDA.)
As a result, Zimmer Biomet is recalling certain polyethylene implants for knees, hips and extremities manufactured between December 2016 and January 2017. Possible long-range health consequences include adverse local tissue reaction; critical pain or ache; and severe, systemic reaction to allergen or toxin, according to the recall notice.
The potentially affected products were distributed between December 2016 and February 2020. The company reported that it has received no complaints related to the potentially affected devices.
The FDA has not issued a recall. Zimmer Biomet did not immediately respond to a request for more information.