The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1240-2017·Announced 2017-03-01

Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date

Smith & Nephew is recalling Dyonics Saw Blades because they are provided sterile but 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, but the source text identifies the issue as a labeling error (missing expiration date) without reporting any illnesses, injuries, or specific contamination, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Smith & Nephew, Inc. is recalling the Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702. The recall involves 2,496 units distributed nationwide and in foreign countries including Brazil, Canada, Chile, China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, and Venezuela.

The reason for the recall is that the single-use devices are provided sterile but do not have an expiration date on the label. The affected batch numbers are 50525150, 50386077, 50261802, 50197616, 50178740, 50171398, 50158656, 50138050, 50121538, 50103379, 50089298, 50082582, and 50061131.

Healthcare providers and consumers should stop using these specific saw blades and contact Smith & Nephew, Inc. for further instructions or a replacement.

The recalled product

Product
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,496

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 →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls