Z-0406-2018Class II

Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone

Name: Z-0406-2018 Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone
Creator: Smith & Nephew, Inc.
Published: 2017-10-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-10-23 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone on 2017-10-23. FDA classified it as Class II and gives the reason as "The expiration date provided on the label is incorrect". 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-0406-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2018-01-24
Terminated: 2018-08-24
Recalling firm: Smith & Nephew, Inc.
Product: Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The expiration date provided on the label is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to [email protected].
Quantity in commerce: 9 units
Distribution: Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
Product codes and lots: Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0406-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0406-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code MDM

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)