The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1574-2014·Announced 2014-05-21

Anspach Cutting Bur Recall Due to Incorrect Product Code Labeling

The Anspach Effort, Inc. is recalling 30 Anspach Cutting Burs (REF L-3SD) because the product code S-3SD was included, which is shorter than the labeled product.

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, but the source text describes a labeling discrepancy (incorrect product code) without reporting any injuries, illnesses, or structural defects. This aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

The Anspach Effort, Inc. is recalling 30 units of the ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length (REF L-3SD). These medical devices are used for cutting and shaping bone, including the spine and cranium, and are intended for use with LONG Attachments.

The recall was initiated because the product code L-3SD contained product code S-3SD, which is shorter in length than the labeled product. This discrepancy indicates a labeling or packaging error where the wrong product code was associated with the item.

The affected units were distributed nationwide, including in Florida, Texas, North Carolina, Illinois, Colorado, and Pennsylvania. The specific lot number for the affected items is G323081803. Healthcare providers and facilities should check their inventory for this specific lot and product code and stop using the affected burs if found.

The recalled product

Product
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
30

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 (1)

  • Lot/Set/Serial: G323081803.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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