Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0274-2014·Announced 2013-11-20

SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation

SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (fit variation) without reporting any specific injuries, illnesses, or deaths. This aligns with the 'Moderate' severity criteria for low-risk contamination or functional issues without reported harm.

Plain-English summary

SpineFrontier, Inc. is recalling 67 units of S-LIFT Extension Shims. These medical devices are manufactured from grade 5 titanium and are designed to slide down retractor blades during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent it from interfering inside the surgical field.

The recall was initiated due to fit variation among all lots of the S-LIFT extension shims. The firm's investigation revealed that the extension shims may not fit down all corresponding retractor blades. This defect could potentially interfere with the intended use of the device during surgery.

The affected products were distributed nationwide, including in Florida, Texas, Oklahoma, Missouri, Illinois, Ohio, Virginia, Oregon, Colorado, Kansas, and Connecticut. Healthcare providers and facilities should stop using these specific shims and contact SpineFrontier, Inc. for instructions on return or replacement.

The recalled product

Product: S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension…
Manufacturer: SpineFrontier, Inc.
Category: Medical Device — Surgical Instrument
Hazard: functional-defect
surgical-interference
Affected units: 67

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 (8)

Part Number/Lot Number: 11-50109 43092R
11-50109 46415
11-50109 CT12H013
11 -50109-1 46415-1
11-50110 43089
11-50110 43089R
11-50110 46416
11-50110-1 46416-1

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same manufacturer · SpineFrontier, Inc.

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