Laguna Monoaxial Pedicle Screw System

• • Terminated Z-0154-2009 FDA Unclassified (pre-2012) ·initiated 21 Aug 2008

  This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.

• • Terminated Z-1820-2008 FDA Unclassified (pre-2012) ·initiated 14 Apr 2008

  This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.

• 19 recalls, same reason

  • Terminated Z-2065-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2069-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2063-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2076-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2067-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2061-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2062-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2075-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2077-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2073-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2068-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2074-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2064-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2071-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2078-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2070-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2060-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2066-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275
  • Terminated Z-2072-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007 ·on shared 510(k) K051275

  This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.

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

510(k) Number

K051275 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Allez Spine Cross Connectors

  Class II

  FDA 510(k) K070460 Active Cleared 11 Jun 2007

• Laguna Size 8 Pedicle Screw

  Class II

  FDA 510(k) K072678 Active Cleared 2 Jul 2008

• Laguna Polyaxial Pedicle Screw System

  Class II

  FDA 510(k) K083826 Active Cleared 22 Jan 2009

• Laguna Size 8 Pedicle Screw System

  Class II

  FDA 510(k) K091995 Active Cleared 7 Aug 2009

• Del Mar Monoaxial Pedicle Screw System

  Class II

  FDA 510(k) K091219 Active Cleared 9 Jul 2009

• Laguna Pedicle Screw System

  Class II

  FDA 510(k) K050060 Active Cleared 4 May 2005