SpineFrontier, Inc.: Recalls

33 recall records from May 10, 2008 to Jun 13, 2019, newest first. Showing 1 to 33.

What this list covers: FDA records filed under the name "SpineFrontier, Inc." and its spelling variant "Spinefrontier".

Back to the SpineFrontier, Inc. profile

NumberClassProductDate
Z-1973-2019Class IIA-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and…Jun 13, 2019
Z-1479-2015Class IISpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number…Mar 5, 2015
Z-0977-2015Class IIlnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164Dec 19, 2014
Z-0576-2014Class IIIndus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior…Nov 20, 2013
Z-0575-2014Class IIIndus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical…Nov 20, 2013
Z-0574-2014Class IIIndus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue…Nov 20, 2013
Z-0573-2014Class IIIndus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior…Nov 20, 2013
Z-0555-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw…Nov 20, 2013
Z-0554-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse…Nov 20, 2013
Z-0553-2014Class IIPedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw…Nov 20, 2013
Z-0544-2014Class IIPedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be…Oct 18, 2013
Z-0778-2014Class IIArena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14…Sep 24, 2013
Z-0777-2014Class IIArena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14…Sep 24, 2013
Z-0776-2014Class IIArena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint…Sep 24, 2013
Z-0624-2014Class IIPedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.Sep 11, 2013
Z-0274-2014Class IIS-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved…Aug 28, 2013
Z-1933-2013Class IIIndus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case…Jun 21, 2013
Z-1665-2013Class IIS-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to…May 24, 2013
Z-1664-2013Class IIBASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all…May 17, 2013
Z-1927-2013Class IIInvue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue…May 10, 2013
Z-1666-2013Class IIInSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are…May 7, 2013
Z-1870-2013Class IIS-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to…Apr 25, 2013
Z-1958-2013Class IICase Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A…Apr 22, 2013
Z-1926-2013Class IIRev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which…Mar 14, 2013
Z-1871-2013Class IIDrill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides…Nov 9, 2012
Z-1869-2013Class IICaddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an…Oct 5, 2012
Z-1932-2013Class IIT-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone…Aug 29, 2012
Z-0412-2013Class IISpine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to…Aug 28, 2012
Z-0417-2013Class IIS-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage…Aug 22, 2012
Z-1957-2013Class IIInvue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw…May 9, 2012
Z-1737-2013Class IIKRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods…Dec 30, 2011
Z-1565-2014Class IISpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion…Dec 23, 2011
Z-1482-2013Class IIStraight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after…May 10, 2008

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.