Z-0352-2018 Class II Terminated
FDA device recall Z-0352-2018 was initiated by Medtronic Sofamor Danek USA Inc on December 6, 2017 and is designated Class II. 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. The recall status is terminated (terminated November 4, 2019). Affected quantity: 3,319 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- December 6, 2017
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,319 units
Product Description
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
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 Pattern
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Code Information
UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575