CLASS II Device recall · Reported 1 Mar 2017 · FDA Enforcement Report

Dyonics Saw Blade, Narrow, Product Number recalled by Smith & Nephew

Smith & Nephew is recalling Dyonics Saw Blade, Narrow, Product Number 3705, distributed nationwide in the US. The recall was initiated on 2 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131

Quantity recalled3462

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1243-2017
FDA event ID: 76414
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 2 Feb 2017
FDA classified: 22 Feb 2017
Reported: 1 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

2 Feb 2017	Recall initiated by company
22 Feb 2017	Classified by FDA	+20 days
1 Mar 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The single use devices are provided sterile and do not have an expiration date on the label.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

Where it was distributed

Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela

Nationwide

Questions about this recall

Why was it recalled?

The single use devices are provided sterile and do not have an expiration date on the label.

Which lots are affected?

Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131

Where was it sold?

Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 76414

This product is part of a recall event; the main page for the event is Dyonics Saw Blade, Standard, Product Number recalled by Smith & Nephew.

Reported	Class	Recall	Company	Reason	Where
1 Mar 2017	CLASS II	Dyonics Saw Blade, Standard, Product Number recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
1 Mar 2017	CLASS II	Dyonics Saw Blade, Short, Narrow, Product Number recalled	Smith & Nephew	Sterility	Nationwide
1 Mar 2017	CLASS II	Dyonics Saw Blade, Short, Product Number recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
1 Mar 2017	CLASS II	Dyonics Saw Blade, Long, Special, Product Number recalled	Smith & Nephew	Sterility	Nationwide
1 Mar 2017	CLASS II	Dyonics Saw Blade, Standard, Thick, Product Number recalled	Smith & Nephew	Sterility	Nationwide

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