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Terminated

Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.

FDA Recall Z-1969-2010 · Posted 2010-07-08

Recalling FirmStarion Instruments
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-02-06
Date Terminated2010-11-27

Reason for Recall

Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.

Firm Action

The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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