Callos Impact and Inject Bone Void Filler

• 11 recalls, same reason

  • Terminated Z-2593-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2611-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2594-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2607-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2623-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2592-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2610-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2622-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2620-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2606-2020 FDA Class II ·initiated 6 Apr 2020
  • Terminated Z-2621-2020 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-2180-2020 FDA Class II ·initiated 2 Apr 2020
  • Terminated Z-2182-2020 FDA Class II ·initiated 2 Apr 2020
  • Terminated Z-2184-2020 FDA Class II ·initiated 2 Apr 2020
  • Terminated Z-2181-2020 FDA Class II ·initiated 2 Apr 2020
  • Terminated Z-2183-2020 FDA Class II ·initiated 2 Apr 2020

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

• • Terminated Z-2209-2015 FDA Class II ·initiated 29 May 2015

  Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.

510(k) Number

K051123 ↗

FDA Product Code

MQV

FDA applicant

Skeletal Kinetics, LLC

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

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

• 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 →