Z-2247-2017Class II

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R

Name: Z-2247-2017 KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R
Creator: Medtronic Sofamor Danek USA Inc
Published: 2017-05-17
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2017-05-17 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R on 2017-05-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2247-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-17
Posted: 2017-06-03
Terminated: 2019-06-18
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Product code: OAR Injector, Vertebroplasty (Does Not Contain Cement)
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
Quantity in commerce: 17657 units
Distribution: worldwide
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2247-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2247-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-03

Product code OAR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)