FDA Recall Terminated

Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #: 7206010. 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.

Recall: Z-1560-2009 · Initiated May 7, 2009

Recall

Recall Number
Z-1560-2009
Event Number
52042
Firm
Smith & Nephew, Inc. Endoscopy Division
FEI Number
3003604053
Product Code
NBH
Status
Terminated
Root Cause
Pending
Initiated
May 7, 2009
Posted
July 14, 2009
Terminated
May 8, 2012
Address
150 Minuteman Drive, Andover, MA, 01810-1031

Description

Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #: 7206010. 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.

Reason

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

Action

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.

Distribution

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.

Quantity

6,432 units