FDAClass IIJanuary 31, 2018

Radial Osteotome Blade recall

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

Why was Radial Osteotome Blade recalled?

The expiration date provided on the label is incorrect.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Recalling firm
Smith & Nephew, Inc.
Quantity
9 units
Distribution
Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
Recall date
January 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls