Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation

• 2 recalls, same reason

  • Terminated Z-1030-2019 FDA Class II ·initiated 5 Jul 2018
  • Terminated Z-1031-2019 FDA Class II ·initiated 5 Jul 2018 ·on shared 510(k) K132365

  the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.

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

510(k) Number

K132365 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Renoir Posterior Cervial Fixation System

  Class II

  FDA 510(k) K121136 Active Cleared 9 Aug 2012

• Cezanne II Interbody Fusion System

  Class II

  FDA 510(k) K131981 Active Cleared 9 Oct 2013

• Picasso II Mis Spinal System

  Class II

  FDA 510(k) K140219 Active Cleared 14 Apr 2014

• DALI Spinal Fixation System

  Class II

  FDA 510(k) K121568 Active Cleared 21 Sep 2012

• Picasso Mis Spinal Fixation System

  Class II

  FDA 510(k) K120714 Active Cleared 9 Aug 2012

• Matisse Anterior Cervical Interbody Fusion Cage System

  Class II

  FDA 510(k) K121569 Active Cleared 27 Jul 2012

See all devices from Accel Spine →