Sequoia Spinal System, Model 3300 Series

• • Terminated Z-2705-2011 FDA Unclassified (pre-2012) ·initiated 4 Apr 2011 ·on shared 510(k) K072672

  A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.

• • Terminated Z-1479-2008 FDA Unclassified (pre-2012) ·initiated 13 Feb 2008

  Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)

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

510(k) Number

K072672 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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