ConMed Stealth Coated Laparoscopic Electrodes with 4mm pin (60-5158 series) as follows: Cat. #60-5158-034 - Spatula, 5 mm x 32 cm; Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.
FDA Recall Z-1413-04 · Posted 2004-08-28
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Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2004-08-09
Date Terminated2005-10-05
Product Quantity1,005 units
Reason for Recall
Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
Firm Action
Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
Root Cause
Other
Distribution Pattern
There are 127 distributors, hospitals and sales representatives in the U.S. There are 21 foreign consignees in Australia, Brazil, Canada, Costa Rica, Ecuador, Finland, India, Israel, Italy, Norway, Peru, Saudi Arabia, Spain, Turkey, United Kingdom, and Venezuela.
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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