Allez Spine, LLC
Irvine, CA, US
Allez Spine, LLC appears in FDA device records in Irvine, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 30 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Allez Spine, LLC between 2005 and 2009. The busiest year on record is 2009, with 3. The most recent is 2009, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091995 | LAGUNA SIZE 8 PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K091219 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K083826 | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K072678 | LAGUNA SIZE 8 PEDICLE SCREW | NKB | Substantially Equivalent | |
| K070460 | ALLEZ SPINE CROSS CONNECTORS | NKB | Substantially Equivalent | |
| K051275 | LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K050060 | LAGUNA PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
Showing 25 of 30| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0155-2009 | Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm | 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-0154-2009 | 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 | 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-0153-2009 | Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635 Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6 x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex Intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. | 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 | Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) | 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. | Terminated | ||
| Z-1819-2008 | Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004) | 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. | Terminated | ||
| Z-2078-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745 | 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. | Terminated | ||
| Z-2077-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740 | 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. | Terminated | ||
| Z-2076-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735 | 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. | Terminated | ||
| Z-2075-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645 | 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. | Terminated | ||
| Z-2074-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640 | 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. | Terminated | ||
| Z-2073-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size (diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655 | 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. | Terminated | ||
| Z-2072-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545 | 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. | Terminated | ||
| Z-2071-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540 | 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. | Terminated | ||
| Z-2070-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535 | 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. | Terminated | ||
| Z-2069-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745 | 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. | Terminated | ||
| Z-2068-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740 | 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. | Terminated | ||
| Z-2067-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR0750 | 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. | Terminated | ||
| Z-2066-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650 | 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. | Terminated | ||
| Z-2065-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640 | 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. | Terminated | ||
| Z-2064-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635 | 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. | Terminated | ||
| Z-2063-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630 | 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. | Terminated | ||
| Z-2062-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545 | 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. | Terminated | ||
| Z-2061-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535 | 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. | Terminated | ||
| Z-2060-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530 | 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. | Terminated | ||
| Z-0191-2008 | Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain