Laguna Pedicle Screw System

• Terminated Z-0153-2009 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-1819-2008 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
• Terminated Z-2069-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2063-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2076-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2067-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2061-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2062-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2075-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2077-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2060-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2072-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2074-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2064-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2071-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2078-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2070-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2066-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2073-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007
• Terminated Z-2068-2008 FDA Unclassified (pre-2012) ·initiated 7 Nov 2007

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.

6 recalls, same reason

• Terminated Z-0189-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007
• Terminated Z-0190-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007
• Terminated Z-0191-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007
• Terminated Z-0187-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007
• Terminated Z-0188-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007
• Terminated Z-0186-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007

Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.