Resolve Open Back Halo Rings

• 4 recalls, same reason

  • Terminated Z-1000-2019 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-1002-2019 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-0999-2019 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-1001-2019 FDA Class II ·initiated 21 Jun 2018

  Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

• 3 recalls, same reason

  • Terminated Z-1507-2009 FDA Unclassified (pre-2012) ·initiated 9 Nov 2008
  • Terminated Z-1508-2009 FDA Unclassified (pre-2012) ·initiated 9 Nov 2008
  • Terminated Z-1509-2009 FDA Unclassified (pre-2012) ·initiated 9 Nov 2008

  Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.

510(k) Number

K051918 ↗

FDA Product Code

HAX

Device Class

Class II

Regulation

21 CFR Part 882.5960

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Warm'n Form Sports Supports

  Class I

  FDA 510(k) K821582 Active Cleared 10 Jun 1982

• JMS Cervical Traction Device/Halo Device

  Class II

  FDA 510(k) K882877 Active Cleared 30 Sep 1988

• Torquedriver Wrench

  Class I

  FDA 510(k) K870053 Active Cleared 11 Mar 1987

• Jms Halo Application Tray

  Class I

  FDA 510(k) K864969 Active Cleared 18 Feb 1987

• Cervical Brace

  Class II

  FDA 510(k) K822780 Active Cleared 6 Oct 1982

• System III Halo Ring

  Class II

  FDA 510(k) K930153 Active Cleared 6 Aug 1993

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