The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1242-2017·Announced 2017-03-01

Smith & Nephew Recalls Dyonics Saw Blades Due to Missing Expiration Dates

Smith & Nephew is recalling 8,748 Dyonics Saw Blades because the single-use sterile devices lack expiration dates on their labels.

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 identifies the issue as a labeling omission (missing expiration date) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Smith & Nephew, Inc. is recalling 8,748 units of the Dyonics Saw Blade, Short, Narrow (Product Number 3704). The recall is being conducted because the single-use devices are provided sterile but do not have an expiration date 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 involves specific batch numbers, including 50525150, 50386077, 50261802, 50197616, 50178740, 50171398, 50158656, 50138050, 50121538, 50103379, 50089298, 50082582, and 50061131.

Healthcare providers and consumers should stop using these products and contact Smith & Nephew for instructions on how to return or dispose of the affected saw blades.

The recalled product

Product
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
8,748

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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