The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1244-2017·Announced 2017-03-01

Smith & Nephew Dyonics Saw Blade Recall Due to Missing Expiration Date

Smith & Nephew is recalling 1,410 Dyonics Saw Blades because the single-use sterile devices lack expiration dates 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, but the source text identifies the issue as a missing expiration date on the label without reporting any illnesses, injuries, or specific contamination hazards, fitting the criteria for moderate severity involving labeling errors.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,410 units of the Dyonics Saw Blade, Long, Special (Product Number 3706). The affected devices are single-use and provided sterile, but they do not have an expiration date on the label.

The recall covers specific batch numbers: 50439354, 50393992, 50252777, 50208023, 50171402, 50138054, 50103142, 50066114, and 576304. These products were distributed nationwide and in foreign countries including Brazil, Canada, Chile, China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, and Venezuela.

Healthcare providers and facilities should stop using the affected devices and contact Smith & Nephew for instructions on return or disposal. The recall is classified as Class II by the FDA.

The recalled product

Product
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,410

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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