Kyphx Inflatable Bone Tamp, Size 20/3, Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A

• 3 recalls, same reason

  • Terminated Z-2389-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2390-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2391-2020 FDA Class II ·initiated 24 Apr 2020

  Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

510(k) Number

K010246 ↗

FDA Product Code

HRX

Models / Variants

K01A

Kyphx Inflatable Bone Tamp

Size 15

3

Model K02A

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B

  Class II

  FDA 510(k) K063071 Active Cleared 13 Apr 2007

• Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular

  Class II

  FDA 510(k) K073516 Active Cleared 21 Feb 2008

• Kyphx Hv-R Bone Cement Model C01A

  Class II

  FDA 510(k) K041584 Active Cleared 7 Jul 2004

• Kyphon Inflatable Bone Tamp

  Class II

  FDA 510(k) K981251 Active Cleared 2 Jul 1998

• Kyphx Hv-R, Model C01A

  Class II

  FDA 510(k) K033801 Active Cleared 1 Apr 2004

• Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B

  Class II

  FDA 510(k) K061210 Active Cleared 27 Jun 2006

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