Agency classClass IIOur severity:High FDA (Devices)·Z-1666-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used for spinal fixation. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High.

Plain-English summary

SpineFrontier, Inc. is recalling the InSpan Inserter, Right Assembly, and InSpan Inserter, Left Assembly. These are stainless steel instruments used in combination to place implants into the body for the InSpan Spinous Plate System. The recall is being conducted because of the potential for a set screw to become deformed.

The recall involves 61 individual inserter assemblies. The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as the Dominican Republic, Medico, and Panama. The specific lot codes for the Right Assembly are 43097, 44614, and 43097R, while the Left Assembly codes are 43098, 44615, and 43098R.

Healthcare providers and consumers should stop using these inserters immediately. Users should contact SpineFrontier, Inc. for further instructions on how to return or replace the affected devices.

The recalled product

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…
Manufacturer: SpineFrontier, Inc.
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
Affected units: 61

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Right Assembly: 43097
44614
43097R
Left Assembly: 43098
44615
43098R

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · SpineFrontier, Inc.

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