ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
FDA Recall Z-1301-04 · Posted 2004-07-31
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Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2004-06-28
Date Terminated2005-10-05
Product Quantity3,252 units
Reason for Recall
Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.
Firm Action
Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
Root Cause
Other
Distribution Pattern
Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
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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