The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1243-2017·Announced 2017-03-01

Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date

Smith & Nephew is recalling 3,462 Dyonics Saw Blades, Narrow (Product Number 3705) because the single-use sterile devices lack an expiration date on the label.

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 involves a labeling error (missing expiration date) on a sterile medical device. This fits the rubric for moderate severity, as it is a labeling issue without reported injuries or deaths.

Plain-English summary

Smith & Nephew, Inc. is recalling 3,462 units of the Dyonics Saw Blade, Narrow, Product Number 3705. The recall is due to a labeling defect where the single-use devices, which are provided sterile, do not have an expiration date printed on the label.

The affected products were distributed nationwide and in foreign countries including Brazil, Canada, Chile, China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, and Venezuela. The recall covers specific batch numbers, including 50525150, 50386077, 50261802, 50197616, 50178740, 50171398, 50158656, 50138050, 50121538, 50103379, 50089298, 50082582, and 50061131.

Healthcare facilities and consumers should stop using these specific saw blades and contact Smith & Nephew for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
3,462

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Smith & Nephew, Inc. 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 6 products in this recall →

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