Device Recall Allez Spine Del Mar Pedicle Screw System

  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
  • Product Description
    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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Allez Spine, LLC, 2301 Dupont Dr Ste 510, Irvine CA 92612-7518
  • Manufacturer Parent Company (2017)
  • Source
    USFDA