Z-2732-2011

DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341

Name: Z-2732-2011 DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-05-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-05-06 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades... on 2011-05-06. The reason FDA records is "Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2732-2011
Status: Terminated
Initiated: 2011-05-06
Posted: 2011-07-01
Terminated: 2012-05-09
Recalling firm: Smith & Nephew, Inc.
Product: DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
Product code: HAB Saw, Powered, And Accessories
Reason for recall: Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to [email protected] for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.
Quantity in commerce: 555 units
Distribution: Worldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.
Product codes and lots: Lot Number: 50561144

Product code HAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)