Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Check against the official notice below — it lists the full affected range.
Medtronic has recalled 3,319 units of the KYPHON Express Directional Bone Filler Device, Size 2 (Ref FB) used in spinal procedures. The recall was initiated because the directional arrow located at the proximal end of the instrument may not properly align with the cut-out opening at the distal end. The affected devices were distributed in the US and multiple international locations including Canada, Austria, Belgium, France, Germany, and others.
The recalled units are identified by specific lot numbers (WI424428 through WI474575) and a UDI of 00643169097254. The source document does not specify a remedy or recommended action for consumers who may have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Reason for recall: Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument. Distribution: US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US Quantity: 3,319 units Lot/code info: UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.