FDA-Device2017-06-14Class II
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Medtronic Sofamor Danek USA Inc
Hazard
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.
Sold states
worldwide
Affected count
17657 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2247-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief