Spinefrontier, Inc.
Beverly, MA
This page shows every FDA and USDA recall linked to Spinefrontier, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
32
Total Recalls
2008
First Recall
2015
Most Recent
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Ro...
Apr 21, 2015
· Device
Terminated
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Jan 14, 2015
· Device
Terminated
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in...
May 7, 2014
· Device
Terminated
Arena-L Trial Handle; Part: 11-81002
The trial heads are smooth plates that mimic the footprint of the implan...
Jan 16, 2014
· Device
Terminated
Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16...
Jan 16, 2014
· Device
Terminated
Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14
The trial hea...
Jan 16, 2014
· Device
Terminated
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Jan 3, 2014
· Device
Terminated
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.
Used to secure the Invue Anterior Cervical Pl...
Dec 26, 2013
· Device
Terminated
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping.
Used to secure the Invue Anterior Cervical Plate in posi...
Dec 26, 2013
· Device
Terminated
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.
Used to secure the Invue Anterior Cervical P...
Dec 26, 2013
· Device
Terminated
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue Anterior Cervical Pla...
Dec 26, 2013
· Device
Terminated
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111
The PedFuse Screw Inserter...
Dec 20, 2013
· Device
Terminated
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113
The PedFuse Screw Inserter 05...
Dec 20, 2013
· Device
Terminated
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110
The PedFuse Screw Inserter 05...
Dec 20, 2013
· Device
Terminated
PedFuse Reset Screw; Model: 01-80115-55
The PedFuse Reset pedicle screw implants intended to be used to help...
Dec 19, 2013
· Device
Terminated
S-LIFT Extension Shims
Extension shims are manufactured from grade 5 titanium and are curved, rectangular slab...
Nov 14, 2013
· Device
Terminated
Invue Solid Driver, Tipped, AO. Part Number: 11-70083.
Allows the user to retain the screw when changing a...
Aug 13, 2013
· Device
Terminated
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-600...
Aug 13, 2013
· Device
Terminated
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Ce...
Aug 8, 2013
· Device
Terminated
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030
Screw inserters are instruments which capture, ho...
Aug 8, 2013
· Device
Terminated
Indus Invue Screw Caddy, Model: SI70097
The caddy holds, in an organized fashion within the case, a variety o...
Aug 8, 2013
· Device
Terminated
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A
T-handles are silicone handled instrument...
Aug 8, 2013
· Device
Terminated
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A
FacetFuse Drill Guides were designe...
Aug 2, 2013
· Device
Terminated
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B
The caddy holds, in an organized fas...
Aug 1, 2013
· Device
Terminated
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A
The slap hammers are used primarily to remove trial ins...
Aug 1, 2013
· Device
Terminated
KRD1 PedFuse Rods, Model: IM80100-13 Rev B
Product Usage: Pedicle rods are cylindrical rods which act as a...
Jul 16, 2013
· Device
Terminated
BASE, S-LIFT Instrument Case
Product Usage:
System cases are designed to hold and secure all instrumentation...
Jul 5, 2013
· Device
Terminated
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly
Product Usage:
Inserters are stainless steel...
Jul 5, 2013
· Device
Terminated
S-LIFT Inserter Outer Sleeve
Product Usage:
The Inserter Sleeve is an optional instrument to add further com...
Jul 5, 2013
· Device
Terminated
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have...
Jun 5, 2013
· Device
Terminated
Spine Frontier Inspan compressors
Part Number: 11-60004.
Inspan compressors provide pressure to drive spikes...
Nov 21, 2012
· Device
Terminated
S-Lift Implant Guides (also known as S-LIF)
Compressor Part Number: 11-50223
Product Usage:
Surgical Guides...
Nov 21, 2012
· Device
Terminated