Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
Reason for recall: Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm. Distribution: TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK Quantity: 84 units Lot/code info: Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.