Recalls / —
—#33813
Product
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 product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K960808
- Affected lot / code info
- Cat. #60-5158-034 with lot #s 0310301, 0402031, 0403051, 0404131; Cat. # 60-5158-234 with lot # 0310081; Cat. #60-5158-432 with lot #s 0310081, 0310301, 0311101, 0401051, 0401121, 0402031, 0403051, 0411121; Cat. # 60-5158-934 with lot #s 0311101, 0401121.
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
Recalling firm
- Firm
- Conmed Corporation
- Address
- 525 French Rd, Utica, New York 13502-5945
Distribution
- 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.
Timeline
- Recall initiated
- 2004-06-28
- Posted by FDA
- 2004-07-31
- Terminated
- 2005-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #33813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.