There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
Reason for recall: There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure. Distribution: US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI. Quantity: 163 US Lot/code info: Lot 19019 UDI-DI 10193489131703
10193489131703
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.