Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
Davol, Inc., Sub. C. R. Bard, Inc. is recalling Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the due to Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026