Date Initiated by Firm | June 19, 2006 |
Date Posted | July 13, 2006 |
Recall Status1 |
Terminated 3 on January 10, 2008 |
Recall Number | Z-1231-06 |
Recall Event ID |
35766 |
510(K)Number | K031675 |
Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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Product | Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible
Part Number: 7209700 |
Code Information |
Lot Numbers: Equal to or lower 50164304 Expanded Recall: Lot Numbers: 50164305, 50165182, 50173175, 50173176 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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For Additional Information Contact | Jason Bilobram 978-474-6332 |
Manufacturer Reason for Recall | Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. |
FDA Determined Cause 2 | Other |
Action | Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product.
Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers. |
Quantity in Commerce | 693 boxes/Expanded 534 units |
Distribution | Nationwide
Foreign: Smith & Nephew Canada, Germany, France, Istanbul |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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