Recalls / —

—#82536

Product

DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006

FDA product code

HRX — Arthroscope

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K051326

Affected lot / code info

0169H, 0299J, 0409K, 0409L, 0409M, 0479U, 0479X, 0489F, 0489H, 0859F, 0899J, 0919F, 1618F, 1618L, 1618LR, 1628F, 1628FR, 1648K, 1648KR, 1758J,1838K, 1908M, 1938F, 2058L, 2528F, 2528FR, 2558F, 2698J, 2748F, 2748P, 2808U, 2838L, 2848H, 2878N, 2908U, 2908V, 3038N, 3048M, and 3258P.

Why it was recalled

The sterility of the device cannot be assured

Root cause (FDA determination)

Package design/selection

Action the firm took

Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.

Recalling firm

Firm

Smith & Nephew, Inc. Endoscopy Division

Address

150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.

Timeline

Recall initiated

2009-05-27

Posted by FDA

2009-09-21

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #82536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.