The Recall Desk

Manufacturer

SpineFrontier, Inc.

33 recalls in our database name SpineFrontier, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
2
Most recent
2019-07-24

Of the 33 recalls from SpineFrontier, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 33

  • HighFDA (Devices)·Z-1973-2019·2019-07-24

    SpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk

    SpineFrontier, Inc. is recalling six A-CIFT SoloFuse Fixed Angle Drivers because they may bind when advancing fixation screws.

    Product
    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1479-2015·2015-04-29

    SpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document

    SpineFrontier is recalling the MISquito Pedicle Screw System Surgical Technique document because it does not adequately convey the intended use of the Rod Caliper.

    Product
    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2015·2015-01-21

    SpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack

    SpineFrontier, Inc. is recalling four Inline Persuader PedFuse Pedicle Screw Systems because a crack may develop in the handle, potentially progressing with continued use.

    Product
    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2014·2014-05-14

    SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage

    SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.

    Product
    SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.

    Product
    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0776-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.

    Product
    Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0778-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, ea
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0575-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0574-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.

    Product
    Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0576-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.

    Product
    Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2014·2014-01-01

    SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect

    SpineFrontier, Inc. is recalling 13 PedFuse Reset Screw Inserters because they may not mate properly with the hex interface of the screws.

    Product
    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0573-2014·2014-01-01

    SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

    SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.

    Product
    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2014·2013-12-25

    SpineFrontier Recalls PedFuse Reset Pedicle Screws Due to Assembly Error

    SpineFrontier, Inc. is recalling 35 PedFuse Reset pedicle screws because one unit was found assembled with the wrong size screw. The recall covers devices distributed to Virginia and Texas.

    Product
    PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0274-2014·2013-11-20

    SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation

    SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.

    Product
    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2013·2013-08-21

    SpineFrontier Invue Solid Driver Recalled Due to Broken Nipple

    SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.

    Product
    Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1958-2013·2013-08-21

    SpineFrontier Recalls Surgical Case Lids and Bases Due to Ink Delamination

    SpineFrontier, Inc. is recalling specific surgical case lids and bases because non-toxic inks used on the graphics are delaminating or running off after repeated washing and sterilization cycles.

    Product
    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1926-2013·2013-08-14

    SpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw

    SpineFrontier, Inc. is recalling eight Rev E PedFuse Return Screw Inserters because a set screw can loosen, causing the collar and locking sleeve to slide off the instrument.

    Product
    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the ins
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1932-2013·2013-08-14

    SpineFrontier T-Handle Strike Plate Separation Recall

    SpineFrontier, Inc. is recalling 11 T-Handles because the strike plate loosened and separated during an operation.

    Product
    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1933-2013·2013-08-14

    SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty

    SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.

    Product
    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an a
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1871-2013·2013-08-14

    SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference

    SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.

    Product
    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1927-2013·2013-08-14

    SpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw

    SpineFrontier, Inc. is voluntarily recalling 12 Invue Split Driver devices due to a device design issue. The recall covers units distributed nationwide.

    Product
    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2013·2013-08-07

    SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments

    SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.

    Product
    Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal
    Category
    Medical Device
    Distribution
    4 states