Manufacturer

SpineFrontier, Inc.

33 recalls in our database name SpineFrontier, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 33
Critical: 0
Severe: 2
Most recent: 2019-07-24

Of the 33 recalls from SpineFrontier, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–33 of 33

ModerateFDA (Devices)·Z-1870-2013·2013-08-07
SpineFrontier Recalls Three S-LIFT Slap Hammers Due to Malfunction
SpineFrontier, Inc. is recalling three S-LIFT Slap Hammers (Lot 56H26) distributed in Kansas and Texas because they malfunctioned.
Product
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar interverte
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1737-2013·2013-07-24
SpineFrontier Recalls KRD1 PedFuse Rods Due to Fatigue Testing Failures
SpineFrontier, Inc. is recalling KRD1 PedFuse Rods because one rod in each of two test constructs failed to meet fatigue requirements during dynamic compression testing.
Product
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be place
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1666-2013·2013-07-10
SpineFrontier Recalls InSpan Inserter Assemblies Due to Set Screw Deformation
SpineFrontier, Inc. is recalling InSpan Inserter assemblies because a set screw may become deformed. The recall covers 61 units distributed worldwide.
Product
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1665-2013·2013-07-10
SpineFrontier Recalls S-LIFT Inserter Outer Sleeve Due to Fit Issue
SpineFrontier, Inc. is recalling 12 S-LIFT Inserter Outer Sleeves because the handle hole is too small to fit the assembly.
Product
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeleta
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2013·2013-07-10
SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating
SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.
Product
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2013·2013-06-12
SpineFrontier Recalls Straight Impactor Devices Due to Handle Plate Breakage
SpineFrontier, Inc. is recalling 10 Straight Impactor - Dorado IBC devices because the impactor plate on the handle broke off during use.
Product
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0417-2013·2012-11-28
SpineFrontier Recalls S-Lift Implant Guides Due to Over-insertion Risk
SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides because using them without stops may allow over-insertion, potentially causing patient injury.
Product
S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2013·2012-11-28
Spine Frontier Inspan Compressors Recalled for Potential Weld Breakage
SpineFrontier, Inc. is recalling 17 Inspan compressors because they may break at the weld, causing a loss of compression during use.
Product
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Category
Medical Device
Distribution
Distributed nationwide