Medtronic KYPHON(R) Express(TM) Directional Bone Filler recall
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Why was Medtronic KYPHON(R) Express(TM) Directional Bone Filler recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575
- Product
- Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 3,319 units
- Distribution
- US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)