SpineFrontier Recalls
33 recalls on record · November 28, 2012 to July 24, 2019 · Medical Devices
Recalls by year
12
13
14
15
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 24, 2019Medical DevicesFDA
SpineFrontier, Inc. recalls A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Hazard: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
April 29, 2015Medical DevicesFDA
SpineFrontier, Inc. recalls SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper
Hazard: The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
January 21, 2015Medical DevicesFDA
SpineFrontier, Inc. recalls lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Hazard: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
May 14, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fus
Hazard: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
January 22, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are
Hazard: Handles and heads may not be compatible.
January 22, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls 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 tr
Hazard: Handles and heads may not be compatible.
January 22, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manuf
Hazard: Handles and heads may not be compatible.
January 15, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Hazard: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in p
Hazard: Mismarked and unmarked screws
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Hazard: Mismarked and unmarked screws
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in
Hazard: Mismarked and unmarked screws
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in po
Hazard: Mismarked and unmarked screws
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset
Hazard: Screw inserters may not mate properly with hex interface of the screws.
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REs
Hazard: Screw inserters may not mate properly with hex interface of the screws.
January 1, 2014Medical DevicesFDA
SpineFrontier, Inc. recalls PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset
Hazard: Screw inserters may not mate properly with hex interface of the screws.
December 25, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide
Hazard: During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
November 20, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which h
Hazard: Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
August 21, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60
Hazard: Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.
August 21, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of i
Hazard: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
August 14, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes
Hazard: Difficulty removing screws from the Invue caddies.
August 14, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that h
Hazard: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
August 14, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Pla
Hazard: Device design.
August 14, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and d
Hazard: Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter.
August 14, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to pro
Hazard: Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
August 7, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments
Hazard: Malfunction of slap hammer.
August 7, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion wit
Hazard: Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
July 24, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking
Hazard: One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
July 10, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instrum
Hazard: Potential for set screw to be come deformed.
July 10, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compressio
Hazard: The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
July 10, 2013Medical DevicesFDA
SpineFrontier, Inc. recalls BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be
Hazard: The S-LIFT Instrument Case contained a bracket with peeling nylon coating.