FDAClass IIAugust 15, 2012

Smith & Nephew 5.5 mm Dyonics Bonecutter recall

Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated…

Why was Smith & Nephew 5.5 mm Dyonics Bonecutter recalled?

Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.

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: 655844R, 950143R, 950144R, 950145R, 950146R

Product
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated…
Recalling firm
Smith & Nephew, Inc. Endoscopy Division
Quantity
108 units
Distribution
Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls