Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
FDA Recall Z-1105-2007 · Posted 2007-08-02
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Recalling FirmSmith & Nephew, Inc Endoscopy Division
Recall StatusTerminated
Product CodeDWQ
Date Initiated2004-10-12
Date Terminated2007-08-02
Product Quantity274 units.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
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.
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