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Class 2 Device Recall Salute |
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Date Initiated by Firm |
December 27, 2006 |
Date Posted |
February 01, 2007 |
Recall Status1 |
Terminated 3 on July 06, 2016 |
Recall Number |
Z-0375-2007 |
Recall Event ID |
36922 |
510(K)Number |
K050610
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Product Classification |
surgical instrument - Product Code GDW
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Product |
Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished) |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Davol, Inc., Sub. C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston RI 02920
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For Additional Information Contact |
Robin Drago 401-463-7000
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Manufacturer Reason for Recall |
Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
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FDA Determined Cause 2 |
Other |
Action |
Davol notified users by a first letter on 12/27/06 providng a introductory letter explaining the Enhanced Servicing Program and changes made to the IFU (re: servicing, tip inspection, end of wire, and test fire protocol). A second letter will issue to accounts to identifying the serial number to be serviced and returned to Davol. |
Quantity in Commerce |
4787 (includes both types) |
Distribution |
Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa. |
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 = GDW and Original Applicant = DAVOL INC., SUB. C.R. BARD, INC.
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