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U.S. Department of Health and Human Services

Class 2 Device Recall Salute

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  Class 2 Device Recall Salute see related information
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  
Product Classification surgical instrument - Product Code GDW
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
For Additional Information Contact Robin Drago
401-463-7000
Manufacturer Reason
for Recall		 Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
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
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.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = DAVOL INC., SUB. C.R. BARD, INC.
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