Recall Z-2247-2017 ยท OAR Injector, Vertebroplasty (Does Not Contain Cement)
Medtronic Sofamor Danek USA Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
| Date | May 17, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtron |
| Quantity | 17657 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.