Opus Minimagnum Anchor with Inserter

• 2 recalls, same reason

  • Terminated Z-0628-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011
  • Terminated Z-0627-2012 FDA Unclassified (pre-2012) ·initiated 8 Aug 2011 ·on shared 510(k) K042584

  Product is being removed from the field due to an over-label issue.

• • Terminated Z-0049-2012 FDA Unclassified (pre-2012) ·initiated 11 May 2011

  ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

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

510(k) Number

K042584 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Opus Magnum Knotless Anchor With Inserter Handle

  Class II

  FDA 510(k) K042914 Active Cleared 12 Nov 2004

• Opus Magnum Implant System, Model Om-1500

  Class II

  FDA 510(k) K031083 Active Cleared 12 Jun 2003

• F1 Diode Laser System

  Class II

  FDA 510(k) K030235 Active Cleared 23 Apr 2003

• Opus Magnum Anchor & Inserter

  Class II

  FDA 510(k) K012125 Active Cleared 17 Sep 2001

• Opus Speedstitch Suture Device

  Class II

  FDA 510(k) K042031 Active Cleared 19 Oct 2004

• Smartstitch M-Connector, Model Om-8005; Smartstitch Actuation Handle, Model Om-8500; and Smartstitch Suture Cartridge

  Class II

  FDA 510(k) K023843 Active Cleared 14 Feb 2003

See all devices from Opus Medical, Inc. →