Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
Reason for recall: Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery Distribution: FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom Quantity: 150 units US; 1116 units OUS Lot/code info: UDI# 00886158001249 LOT#'s: 6034831,6039837
00886158001249
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.