Recalls / —
—#34612
Product
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 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, Lot #s 0309121; Cat #60-5158-432, Lot #s 0308071, 0309021, 0309151, 1121; Cat #60-5158-934, Lot #s 0309111;
Why it was recalled
Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
Root cause (FDA determination)
Other
Action the firm took
Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
Recalling firm
- Firm
- Conmed Corporation
- Address
- 525 French Rd, Utica, New York 13502-5945
Distribution
- 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.
Timeline
- Recall initiated
- 2004-08-09
- Posted by FDA
- 2004-08-28
- Terminated
- 2005-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.