Z-2144-2012Class II

Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213

Name: Z-2144-2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2012-07-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2012-07-14 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is... on 2012-07-14. FDA classified it as Class II and gives the reason as "Devices 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". 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-2144-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-14
Posted: 2012-08-03
Terminated: 2021-03-22
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Devices 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 340 units
Distribution: Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
Product codes and lots: Lot Numbers: 950135R, 950136R, 950137R, 950138R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2144-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2144-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-03
Z-2145-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-03

Product code GEI

K012314Class IIDyonics Electroblade ResectorSmith & Nephew, Inc. / cleared 2002-02-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)