Vanguard Reprocessed Arthroscopic Wands

• • Terminated Z-1204-2012 FDA Unclassified (pre-2012) ·initiated 1 Jun 2009

  On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09.

• 4 recalls, same reason

  • Terminated Z-1670-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008 ·on shared 510(k) K012695
  • Terminated Z-1681-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008 ·on shared 510(k) K012695
  • Terminated Z-1667-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008 ·on shared 510(k) K012695
  • Terminated Z-1668-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008 ·on shared 510(k) K012695

  Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

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

510(k) Number

K012695 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Vanguard Reprocessed Non-Electric Biopsy Forceps

  Class I

  FDA 510(k) K042594 Active Cleared 25 Jan 2005

• Vanguard Reprocessed Femoral Compression Device

  Class II

  FDA 510(k) K011832 Active Cleared 21 Dec 2001

• Vanguard Reprocessed Diagnostic Electrophysiology Catheters

  Class II

  FDA 510(k) K042074 Active Cleared 9 Mar 2005

• Vanguard Reprocessed Compression Garment

  Class II

  FDA 510(k) K012403 Active Cleared 17 Oct 2001

• Reprocessed Disposable Cutters, Staplers and Appliers

  Class II

  FDA 510(k) K032973 Active Cleared 18 Dec 2003

• Vanguard Reprocessed Dilating Tip and Blunt Trocars

  Class II

  FDA 510(k) K043253 Active Cleared 8 Apr 2005

See all devices from Vanguard Medical Concepts, Inc. →