—#81979

Product

Smith & Nephew Endoscopic Disposable Blades: BOXED F/R,BL,4.5MM,SERIES 3000 /6 Product #: 7206011. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.

FDA product code: NBH — Accessories, Arthroscopic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot #: 20148714 and 20153849.

Why it was recalled

Product sterility is compromised due to breach in the sterile packaging.

Root cause (FDA determination)

Pending

Action the firm took

Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Timeline

Recall initiated: 2009-05-07
Posted by FDA: 2009-07-14
Terminated: 2012-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81979. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.