This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
Dimensional non-conformity of the thread on the screw head.
Dimensional non-conformity of the thread on the screw head.
Dimensional non-conformity of the thread on the screw head.
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.