Osteovation Cmf Bone Void Filler

• 6 recalls, same reason

  • Terminated Z-2615-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2614-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2619-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2617-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2618-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2616-2020 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.

• 5 recalls, same reason

  • Terminated Z-2191-2020 FDA Class II ·initiated 2 Apr 2020 ·on shared 510(k) K051784
  • Terminated Z-2187-2020 FDA Class II ·initiated 2 Apr 2020 ·on shared 510(k) K051784
  • Terminated Z-2189-2020 FDA Class II ·initiated 2 Apr 2020 ·on shared 510(k) K051784
  • Terminated Z-2188-2020 FDA Class II ·initiated 2 Apr 2020 ·on shared 510(k) K051784
  • Terminated Z-2190-2020 FDA Class II ·initiated 2 Apr 2020 ·on shared 510(k) K051784

  Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

• 2 recalls, same reason

  • Terminated Z-0866-2021 FDA Class II ·initiated 6 Jun 2019
  • Terminated Z-0867-2021 FDA Class II ·initiated 6 Jun 2019

  A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K051784 ↗

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

• OsteoVation Impact

  Class II

  FDA 510(k) K162864 Active Cleared 13 Jan 2017

• 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

See all devices from Skeletal Kinetics LLC →