Z-1105-2007

Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc...

Name: Z-1105-2007 Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc...
Creator: Smith & Nephew, Inc Endoscopy Division
Published: 2004-10-12
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2004-10-12 / Terminated

FDA source

Smith & Nephew, Inc Endoscopy Division began a recall of Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810 on 2004-10-12. The reason FDA records is "Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1105-2007
Status: Terminated
Initiated: 2004-10-12
Posted: 2007-08-02
Terminated: 2007-08-02
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Product code: DWQ Stripper, Vein, External
Reason for recall: Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
FDA root cause: Other
Action: Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.
Quantity in commerce: 274 units.
Distribution: Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
Product codes and lots: Pnuematic Footswitch part of TRIVEX System with the following serial numbers: 105, 106, 108, 109, 111 -123, 125 - 182, 184 - 188, 192 - 197, 199 - 203, 205 - 219, 222 - 249, 252 - 254, and 7210386.

Product code DWQ

K032387Class IITrivex SystemSmith & Nephew, Inc. / cleared 2003-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)