Veritas Dry Collagen Matrix, Veritas Dry or Veritas Psd

• • Terminated Z-0274-2012 FDA Unclassified (pre-2012) ·initiated 26 Oct 2011

  Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.

• 5 recalls, same reason

  • Terminated Z-0963-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007
  • Terminated Z-0961-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007
  • Terminated Z-0964-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007
  • Terminated Z-0965-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007
  • Terminated Z-0962-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007

  Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.

• • Terminated Z-0960-2007 FDA Unclassified (pre-2012) ·initiated 16 Mar 2007

  Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.

• • Terminated Z-0764-06 FDA Unclassified (pre-2012) ·initiated 1 Nov 2005

  The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

510(k) Number

K041669 ↗

FDA Product Code

FTM

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Veritas Collagen Matrix

  Class II

  FDA 510(k) K030879 Active Cleared 24 Apr 2003

• Synovis Collagen Matrix (Tbd)

  Class II

  FDA 510(k) K122306 Active Cleared 8 Mar 2013

• Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement

  Class II

  FDA 510(k) K040415 Active Cleared 14 Apr 2004

• Steerable Stylet

  Class II

  FDA 510(k) K040001 Active Cleared 9 Mar 2004

• Veritas Collagen Matrix (Dry)

  Class II

  FDA 510(k) K083039 Active Cleared 26 Nov 2008

• Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration

  Class II

  FDA 510(k) K040119 Active Cleared 17 Mar 2004

See all devices from Synovis Surgical Innovations →