DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew

FDA device recall Z-2732-2011 · posted 2011-07-01 · Terminated

Recall details

Recalling firm

Smith & Nephew, Inc. Endoscopy Division

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

HAB

Quantity affected

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 Kin

Date initiated

2011-05-06

Date posted

2011-07-01

Date terminated

2012-05-09

Location

Andover, MA