Class 2 Device Recall Allez Spine Del Mar Pedicle Screw System

• Date Initiated by Firm: August 21, 2008
• Date Posted: October 28, 2008
• Recall Status: Terminated on January 19, 2010
• Recall Number: Z-0154-2009
• Recall Event ID: 49444
• 510(K)Number: K051275
• Product Classification: Spinal Pedicle Fixation - Product Code NKB
• Product: Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001; Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); ; IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher;; lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001; Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl Bearing); IT-CT1002 Counter Torque (Short No Windows); ; IT-SD1006 Multiaxial Screwdriver (w/Windows);; IT-TP1005 Tap, 4mm (Silver Tn-Fluted);; IT-TP1006 Tap, 5mm (Silver Tn-Fluted);; IT-TP1007 Tap, 6mm (Silver Tn-Fluted);; IT-TP1008 Tap, 7mm (Silver Tn-Fluted); ; lT-HP1002 Head Positioner (All Metal Handle);; IT-RK1002 Rocker (Horse Shoe Style Tip);; IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing);; IT-CT1003 Counter Torque (Short w/Windows);; IT-TP1014 Tap, 4mm (Silver Circumferential);; IT-TP1015 Tap, 5mm (Silver Circumferential);; IT-TP1016 Tap, 6mm (Silver Circumferential);; IT-TP1017 Tap, 7mm (Silver Circumferential);; IT-SD1007 Screwdriver Shaft 8.5 (No Ball Bearing);; IT-XR1001 Extension Remover;; IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing);; IT-FB1001 French Rod Bender;; IT-SP1001 Ball Tip Probe;; IT-TR1001 Trial Rod;; IT-RG 1002 Rod Gripper, Ratcheting (Short Nose);; IT-BP1003 Lumbar Probe, Straight (Long);; IT-BP1004 Lumbar Probe, Curved (Long);; IT-SP1002 Sounder (Ball Tip) Probe, Heavy Duty;; RD-ST5540 Rod 5,5 x 400mm, Straight;; IT-BA1001 Newport Awl;; IT-PU 1001 Persuader; ; IT-RR1001 Retaining Ring;; lT-NS1001 In-Situ Left;; IT-N51002 In-Situ Right;; IT-BP100S Lumbar Probe, Straight (Short);; IT-BP1006 Lumbar Probe, Curved (Short);; IT-CP1001 Compressor;; IT-DT1001 Distractor;; IT-BP1001 Thoracic Ball Handle Probe, Curved;; IT-BP1002 Thoracic Ball Handle Probe, Straight;; IT-RH1002 Ratcheting T-Handle;; IT-NC1001 Locking Nut Caddy;; IT-SG1001 Screw Gauge Block;; IT-RH1002 Ratcheting Handle, Straight;; IT-T01002 Preset Torque Wrench (With Connector);; LG-LN1002 Locking Nut, Single Piece;; LG-PR0530C Polyaxial Screw, Non-Winged, 5 X 30;; LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35;; LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40;; LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45;; LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50;; LG-PR0630C Polyaxial Screw, Non-Winged, 6 X 30;; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35;; LG-PR0640C Polyaxial Screw, Non-Winged, 6 X 40;; LG-PR0645C Polyaxial Screw, Non-Winged, 6 X 45;; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50;; LG-PR0730C Polyaxial Screw, Non-Winged, 7 X 30;; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35;; LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40;; LG-PR074SC Polyaxial Screw, Non-Winged, 7 X 45;; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50;; LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55;; LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35;; LG-PR0840C Polyaxial Screw, Non-Winged, 8 X 40;; LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45;; LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50;; LG-PR0855C Polyaxial Screw, Non-Winged, 8)( 55;; LG-PW0535C Polyaxial Screw, Winged, S X 35;; LG-PW0540C Polyaxial Screw, Winged, 5 X 40;; LG-PW0545C Polyaxial Screw, Winged, 5 X 45;; LG-PW0635C Polyaxial Screw, Winged, 6 X 35;; LG-PW0640C Polyaxial Screw, Winged, 6 X 40;; LG-PW0645C Polyaxial Screw, Winged, 6 X 45;; LG-PW0735C Polyaxial Screw, Winged, 7 X 35;; LG-PW0740C Polyaxial Screw, Winged, 7 X 40;; LG-PW0745C Polyaxial Screw, Winged, 7 X 45;; RD-PB5504 ROD 5.5 X 40, PRE-BENT;; RD-PB5505 ROD 5.5 X 50, PRE-BENT;; RD-PB5506 ROD 5.5 X 60, PRE-BENT;; RD-PB5507 ROD 5.5 X 70, PRE-BENT;; RD-PB5508 ROD 5.5 X 80, PRE-BENT;; RD-PB5509 ROD 5.5 X 90, PRE-BENT;; RD-PB5510 ROD 5.5 X 100, PRE-BENT;; RD-PB5511 ROD 5.5 X 110, PRE-BENT;; RD-PB5
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: Allez Spine, LLC; 2301 Dupont Dr Ste 510; Irvine CA 92612-7518
• For Additional Information Contact: Mark De Baca; 800-939-7008
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Pending
• Action: Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.
• Quantity in Commerce: 6472 units for all systems
• Distribution: Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKB and Original Applicant = ALLEZ SPINE, LLC