Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0933-2021·Announced 2021-02-10

Smith & Nephew Recalls Versabond AB Bone Cement Due to Heat Exposure

Smith & Nephew is recalling 5,190 units of Versabond AB bone cement due to potential heat and humidity exposure that altered the product's consistency.

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 hazard involves potential exposure to environmental factors resulting in a physical consistency change, without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 5,190 units of Versabond AB 40 Grams Formulation 2, an antibiotic-infused bone cement used for hip, knee, and shoulder implant fixation. The recall is due to potential heat and humidity exposure, which caused the affected lot to exhibit an atypical sandy, flaky, or grainy consistency when mixed.

The affected product is identified by Product Number 71271440 and Batch Number 18LC07540. The devices were distributed worldwide, including in the United States (specifically Ohio) and in Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.

Healthcare providers and patients should check their inventory and records for this specific batch number. If the product has been used, patients should contact their healthcare provider to discuss the potential impact on their implant fixation.

The recalled product

Product: VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Bone Cement
Hazard: heat-exposure
humidity-exposure
product-consistency
Affected units: 5,190

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 (2)

Product Number: 71271440
Batch Number: 18LC07540

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Smith & Nephew, Inc.

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