—#100188

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.

FDA product code: HAB — Saw, Powered, And Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number: 50561144

Why it was recalled

Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.

Root cause (FDA determination)

Process control

Action the firm took

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 endo.andreturn@smith-nephew.com 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.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-05-06
Posted by FDA: 2011-07-01
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100188. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.