—#155810

Product

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

FDA product code: OAR — Injector, Vertebroplasty (Does Not Contain Cement)
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All Lots

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 Medtronic Sales Representative to coordinate the return and replacement of affected product.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2017-05-17
Terminated: 2019-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.