Spinefrontier recalls
Spinefrontier appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2019-07-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 33 |
|---|---|
| Published | 2012-11-28 to 2019-07-24 |
| By agency | FDA Device (33) |
| By classification | Class II (33) |
| By status | terminated (33) |
| Distribution named in notices | AZ, CO, CT, DC, FL, IL, KS, MA, MD, MO, MS, NV, NY, OH, OK, PR, TX, US, VA, WA |
Recalls
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
FDA Device · Class II · 2019-07-24 · Spinefrontier
Reason: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. - SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique
FDA Device · Class II · 2015-04-29 · Spinefrontier
Reason: 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. - lnline Persuader- PedFuse Pedicle Screw System
FDA Device · Class II · 2015-01-21 · Spinefrontier
Reason: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. - SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery
FDA Device · Class II · 2014-05-14 · Spinefrontier
Reason: 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: Impac… - Arena-L 38x28Trial Head I 10¿ Lordotic
FDA Device · Class II · 2014-01-22 · Spinefrontier
Reason: Handles and heads may not be compatible. - Arena-L Trial Handle
FDA Device · Class II · 2014-01-22 · Spinefrontier
Reason: Handles and heads may not be compatible. - Arena-L 35x26 Trial Head I 10¿ Lordotic
FDA Device · Class II · 2014-01-22 · Spinefrontier
Reason: Handles and heads may not be compatible. - PedFuse Bone Probe
FDA Device · Class II · 2014-01-15 · Spinefrontier
Reason: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. - Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Mismarked and unmarked screws - Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Mismarked and unmarked screws - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Screw inserters may not mate properly with hex interface of the screws. - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Screw inserters may not mate properly with hex interface of the screws. - Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Mismarked and unmarked screws - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Screw inserters may not mate properly with hex interface of the screws. - Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling
FDA Device · Class II · 2014-01-01 · Spinefrontier
Reason: Mismarked and unmarked screws - PedFuse Reset Screw
FDA Device · Class II · 2013-12-25 · Spinefrontier
Reason: 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 initi… - S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions…
FDA Device · Class II · 2013-11-20 · Spinefrontier
Reason: 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. - Invue Solid Driver, Tipped, AO. Part Number: 11-70083
FDA Device · Class II · 2013-08-21 · Spinefrontier
Reason: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. - Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C)
FDA Device · Class II · 2013-08-21 · Spinefrontier
Reason: 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. - Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates a…
FDA Device · Class II · 2013-08-14 · Spinefrontier
Reason: Difficulty removing screws from the Invue caddies. - Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(…
FDA Device · Class II · 2013-08-14 · Spinefrontier
Reason: Device design. - Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw asse…
FDA Device · Class II · 2013-08-14 · Spinefrontier
Reason: 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 plac… - Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev
FDA Device · Class II · 2013-08-14 · Spinefrontier
Reason: 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. - T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end
FDA Device · Class II · 2013-08-14 · Spinefrontier
Reason: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. - Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev
FDA Device · Class II · 2013-08-07 · Spinefrontier
Reason: 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. - S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to esti…
FDA Device · Class II · 2013-08-07 · Spinefrontier
Reason: Malfunction of slap hammer. - KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicl…
FDA Device · Class II · 2013-07-24 · Spinefrontier
Reason: 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. - BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical sys…
FDA Device · Class II · 2013-07-10 · Spinefrontier
Reason: The S-LIFT Instrument Case contained a bracket with peeling nylon coating. - S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into t…
FDA Device · Class II · 2013-07-10 · Spinefrontier
Reason: 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. - InSpan Inserter, Right Assembly
FDA Device · Class II · 2013-07-10 · Spinefrontier
Reason: Potential for set screw to be come deformed. - Straight Impactor - Dorado IBC, Part Number: SI02140
FDA Device · Class II · 2013-06-12 · Spinefrontier
Reason: During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. - S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implan…
FDA Device · Class II · 2012-11-28 · Spinefrontier
Reason: When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for inj… - Spine Frontier Inspan compressors Part Number: 11-60004
FDA Device · Class II · 2012-11-28 · Spinefrontier
Reason: Inspan Compressors may break at weld causing a loss of compression