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Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade recallZ-2145-2012 · Smith & Nephew, Inc. Endoscopy Division · initiated Jul 14, 2012

Class II Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. Endoscopy Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Error in labeling

What the company is doing

Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to [email protected]. They will provide customers with instructions for returning affected products and receiving a credit. Each OUS affiliate shall be notified via (email or equivalent) of the recall by Smith & Nephew Inc.; the affiliate must then notify each facility affected by the recall. For question concerning this recall call 405-917-8585 or 978-749-1630.

Recall details

Recall number
Z-2145-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 14, 2012
Posted by the FDA
Aug 3, 2012
Recalling firm
Smith & Nephew, Inc. Endoscopy Division
Quantity
108 units
Product code
GEI
FDA submissions
K012314
Distribution
Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.

Product description

Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

2 devices cleared under K012314 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62617).

Sources and updates

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