Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished)
FDA Recall Z-0374-2007 · Posted 2007-02-01
Advertisement
Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeGDW
Date Initiated2006-12-27
Date Terminated2016-07-06
Product Quantity4787 (includes both types)
Reason for Recall
Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement