Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished)
Hazard
Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
What You Should Do
Remedy
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.
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Products
Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall.
Reference Number 0113036 or 9113036(refurbished)
- Brand
- Davol, Inc., Sub. C. R. Bard, Inc.
- UPC
- All serial numbers
Units Affected
4787 (includes both types)