RecallRadar

FDA Device recall Z-0406-2018

Radial Osteotome Blade, REF 71369314

On 2018-01-31 the FDA classified a Class II recall of Radial Osteotome Blade, REF 71369314 by Smith And Nephew, citing the expiration date provided on the label is incorrect.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0406-2018
ClassificationClass II
Statusterminated
Initiated2017-10-23
Published2018-01-31
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew
DistributionNJ, TN

Product

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

Reason

The expiration date provided on the label is incorrect.

Identifiers

code_infoLot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0406-2018%22

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