Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2145-2012·Announced 2012-08-15

Smith & Nephew Dyonics Bonecutter Recalled for Incorrect Expiry Labeling

Smith & Nephew is recalling 108 units of the 5.5 mm Dyonics Bonecutter because the devices are labeled with a 48-month expiry instead of the validated 36-month period.

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 is a labeling error regarding expiry dates without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 108 units of the 5.5 mm Dyonics Bonecutter, Electroblade Full Radius (Part Number 7205962). The recall involves specific lot numbers: 655844R, 950143R, 950144R, 950145R, and 950146R. The product is indicated for use in arthroscopic surgical procedures for soft and osseous tissue resection and hemostasis.

The reason for the recall is that the devices are labeled with an expiry period of 48 months instead of the correct 36 months. The additional 12 months of shelf life have not been validated for product and package reliability. This labeling error could potentially affect the performance of the device if used beyond the validated period.

The affected units were distributed worldwide, including the United States, Australia, Canada, Korea, Turkey, the UAE, and Japan. Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product: Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is…
Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Category: Medical Device — Surgical Instrument
Hazard: mis-labeling
Affected units: 108

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 (5)

Lot Numbers: 655844R
950143R
950144R
950145R
950146R

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Smith & Nephew, Inc. Endoscopy Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Smith & Nephew, Inc. Endoscopy Division

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Same hazard · mis labeling