Z-1239-2017Class II

Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701

Name: Z-1239-2017 Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Creator: Smith & Nephew, Inc.
Published: 2017-02-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-02-02 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 on 2017-02-02. FDA classified it as Class II and gives the reason as "The single use devices are provided sterile and do not have an expiration date on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1239-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-02
Posted: 2017-02-22
Terminated: 2019-09-20
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Product code: HAB Saw, Powered, And Accessories
Reason for recall: The single use devices are provided sterile and do not have an expiration date on the label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Smith & Nephew, Inc. initiated recall by letter on 2/2/17 advising of the problem, requesting inspection of inventory and return of product. Contact Smith & Nephews Field Actions Department via email at [email protected] or fax +1-901-566-7975 to return.
Quantity in commerce: 2646
Distribution: Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela
Product codes and lots: Batch Numbers: 50586138 50458123 50418120 50339534 50306882 50285907 50248565 50231427 50197615 50171397 50158655 50138049 50119457 50089297 50082581 50069485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1239-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1240-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1241-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1242-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1243-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22
Z-1244-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code HAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)