Recall StatusCompleted
Date Initiated2022-03-03
Product Quantity7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
Reason for Recall
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Firm Action
On 03/03/22, a Field Safety Notice was sent via courier service to customers.
In section 4, "Actions to be taken by the Customer/User" of the Field Safety Notice includes the following:
Place the customer communication with the User Manual. In addition,
1. Read and understand the contents of the letter.
2. Notify all surgeons and personnel using the System that they should reacquaint themselves by
a. Reading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual
b. Contacting Sales Representatives for clarification of queries.
3. Complete the Acknowledgement Form immediately and return it via fax or email as instructed on the form.
4. Retain a copy of the letter and the acknowledgement form for your files.
5. Inform of any adverse events/serious incidents or quality problems concerning the use of the subject devices via the standard complaint process.
6. Additionally, if adverse events/serious incidents or quality problems are experienced, follow the standard reporting process to the health authority, if applicable.
The use of the instruments may be continued by following instructions provided in Section 1 of the notice and warnings and cautions listed in the user manuals.
There will be follow up with updated user documentation once available.
If further information is needed or support concerning the Medical Device Correction, contact the Clinical Sales Representative or contact Customer Service at the numbers listed below:
" US, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail:
[email protected]
" Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or
[email protected]
" South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or
[email protected]
" Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or
[email protected]
" Taiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Ta
Distribution Pattern
Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
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.