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Spinefrontier, Inc. Recalls

22 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Spinefrontier, Inc..

22Total Recalls
0Critical
1,293Units Affected
Jun 13, 2019Most Recent
All Recalls

Every Spinefrontier, Inc. Recall

Sorted by most recent. Click any recall for full details.

22 recalls
High RiskFDA
Spinefrontier, Inc.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Medical Devices·6 affected·Jun 13, 2019
High RiskFDA
Spinefrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgi...
Surgical Devices·5 affected·Mar 5, 2015
High RiskFDA
Spinefrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Medical Devices·4 affected·Dec 19, 2014
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserte...
Medical Devices·25 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·922 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter ...
Medical Devices·4 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization an...
Medical Implants·35 affected·Oct 18, 2013
High RiskFDA
Spinefrontier, Inc.
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 smo...
Medical Implants·23 affected·Sep 24, 2013
High RiskFDA
Spinefrontier, Inc.
Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4...
Medical Implants·23 affected·Sep 24, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Medical Devices·13 affected·Sep 11, 2013
High RiskFDA
Spinefrontier, Inc.
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusi...
Surgical Devices·67 affected·Aug 28, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of pla...
Medical Devices·13 affected·Jun 21, 2013
High RiskFDA
Spinefrontier, Inc.
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 5...
Medical Devices·12 affected·May 10, 2013
High RiskFDA
Spinefrontier, Inc.
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an...
Medical Implants·61 affected·May 7, 2013
High RiskFDA
Spinefrontier, Inc.
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle scre...
Medical Implants·8 affected·Mar 14, 2013
High RiskFDA
Spinefrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric...
Medical Implants·13 affected·Nov 9, 2012
High RiskFDA
Spinefrontier, Inc.
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm...
Medical Implants·11 affected·Oct 5, 2012
High RiskFDA
Spinefrontier, Inc.
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into ...
Medical Implants·17 affected·Aug 28, 2012
High RiskFDA
Spinefrontier, Inc.
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to pla...
Medical Implants·19 affected·Aug 22, 2012
High RiskFDA
Spinefrontier, Inc.
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between...
Medical Implants·2 affected·Dec 30, 2011
High RiskFDA
Spinefrontier, Inc.
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc...
Medical Implants·10 affected·May 10, 2008