Modification to: Bioknotless Br Anchor / Lupine Br Anchor

• 5 recalls, same reason

  • Ongoing Z-1680-2023 FDA Class II ·initiated 13 Apr 2023
  • Ongoing Z-1678-2023 FDA Class II ·initiated 13 Apr 2023
  • Ongoing Z-1681-2023 FDA Class II ·initiated 13 Apr 2023
  • Ongoing Z-1679-2023 FDA Class II ·initiated 13 Apr 2023
  • Ongoing Z-1677-2023 FDA Class II ·initiated 13 Apr 2023

  IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

• 5 recalls, same reason

  • Terminated Z-0315-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0316-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0314-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0317-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011
  • Terminated Z-0318-2012 FDA Unclassified (pre-2012) ·initiated 31 Oct 2011

  Incorrect suture configuration

• • Terminated Z-1810-2008 FDA Unclassified (pre-2012) ·initiated 29 Apr 2008 ·on shared 510(k) K070925

  Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.

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

510(k) Number

K070925 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• OmniSpan Meniscal Repair SYSTEM/0 Degree, Model 228140, RapidLoc A2 Meniscal Repair SYSTEM/12 Degree, Model 228141

  Class II

  FDA 510(k) K092836 Active Cleared 4 Feb 2010

• Rotator Cuff Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052630 Active Cleared 17 Oct 2005

• Omnicut Resection Blade

  Class II

  FDA 510(k) K130912 Active Cleared 14 Jun 2013

• Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

  Class II

  FDA 510(k) K103831 Active Cleared 21 Jul 2011

• Milagro Interference Screw

  Class II

  FDA 510(k) K060830 Active Cleared 15 Jun 2006

• Super Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052631 Active Cleared 21 Oct 2005

See all devices from Depuy Mitek, A Johnson & Johnson Company →