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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew Endoscopic Disposable Blades

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  Class 2 Device Recall Smith & Nephew Endoscopic Disposable Blades see related information
Date Initiated by Firm May 07, 2009
Date Posted July 14, 2009
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1566-2009
Recall Event ID 52042
Product Classification Endoscopic Disposable Blades - Product Code NBH
Product Smith & Nephew Endoscopic Disposable Blades:
Part #: 7205312.

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.
Code Information Lot #: 20153858.
Recalling Firm/
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Product sterility is compromised due to breach in the sterile packaging.
FDA Determined
Cause 2
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.
Quantity in Commerce 168 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.