OsteoVation Impact

• 6 recalls, same reason

  • Terminated Z-2599-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2634-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2598-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2633-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2597-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2635-2020 FDA Class II ·initiated 6 Apr 2020

  Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

• • Terminated Z-2054-2020 FDA Class II ·initiated 3 Apr 2020

  Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.

510(k) Number

K162864 ↗

FDA Product Code

GXP

FDA applicant

Skeletal Kinetics, LLC

Device Class

Class II

Regulation

21 CFR Part 882.5300

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo Vation

  Class II

  FDA 510(k) K100986 Active Cleared 20 Jul 2010

• Skaffold Cis

  Unclassified

  FDA 510(k) K111538 Active Cleared 25 Oct 2011

• Callos Impact and Inject Bone Void Filler

  Class II

  FDA 510(k) K051123 Active Cleared 3 Jun 2005

• Skaffold Nmx Bone Void Filler

  Class II

  FDA 510(k) K132211 Active Cleared 4 Aug 2014

• Callos Promodel Bone Void Filler, Skaffold Mp (Macro Porous) Bone Void Filler

  Class II

  FDA 510(k) K112383 Active Cleared 7 Feb 2012

• Callos

  Class II

  FDA 510(k) K030554 Active Cleared 20 May 2003

See all devices from Skeletal Kinetics LLC →