KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
FDA Recall Z-2247-2017 · Posted None
Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeOAR
Date Initiated2017-05-17
Date Terminated2019-06-18
Product Quantity17657 units
Reason for Recall
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
Firm Action
Medtronic distributed a voluntary removal notice (Attachment I) via FedEx courier service to impacted U.S. consignees on 17 May 2017. Communications to impacted consignees outside the United States are currently ongoing per each geographies local procedures.
The consignees were directed to do the following:
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 via fax to 763-367-8134, or via e-mail to [email protected].
3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
Root Cause
Nonconforming Material/Component
Distribution Pattern
worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.