Device recall

Z-1209-2009: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured…

FDA device recall · Class II · Medtronic Spine LLC, formerly Kyphon Inc

Key facts

Recall number (Z-number) Z-1209-2009
Recall event 51206
Product KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Product code HRX
Recalling firm Medtronic Spine LLC, formerly Kyphon Inc
Recall class Class II
Status Terminated
Termination date Jul 14, 2009
510(k) numbers K041454
FEI number 3004904811

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)