Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Recall Z-0352-2018 · Posted None
Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeOAR
Date Initiated2017-12-06
Date Terminated2019-11-04
Product Quantity3,319 units
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.
Firm Action
Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following:
"If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel
within your facility as appropriate, and maintain a copy of this notice in your records.
Instructions to Customers:
1.) Please locate and remove the impacted product from normal storage locations. Do not use this product.
2.) Complete the enclosed Customer Confirmation Form and return
3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product."
Root Cause
Process control
Distribution Pattern
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.