Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00

• • Terminated Z-3033-2011 FDA Unclassified (pre-2012) ·initiated 15 Mar 2011

  This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain.

510(k) Number

K062391 ↗

FDA Product Code

MRW

Models / Variants

Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 And 9045-02

Compression Tool, Model 6113-00

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• 4.5mm Bone-Lok Facet Screw, Models Tfcd-45-3040S or N; Sfcd-45-3040S or N

  Unclassified

  FDA 510(k) K043351 Active Cleared 18 Feb 2005

• Helical Compression Anchor System, Non-Cannulated

  Class II

  FDA 510(k) K012817 Active Cleared 20 Nov 2001

• Helical Compression Anchor System, Cannulated Single Helix

  Class II

  FDA 510(k) K012818 Active Cleared 20 Nov 2001

• 3.8mm Cs Facet Compression Device

  Unclassified

  FDA 510(k) K052043 Active Cleared 17 Oct 2005

• Titanium Compression Anchor System Model Version 2

  Class II

  FDA 510(k) K012280 Active Cleared 17 Aug 2001

• Bone-Lok Hp Washer

  Class II

  FDA 510(k) K040250 Active Cleared 23 Mar 2004

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