ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-
FDA device recall Z-1301-04 · posted 2004-07-31 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- 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.
- Action taken
- Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 3,252 units
- Distribution
- Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
- Date initiated
- 2004-06-28
- Date posted
- 2004-07-31
- Date terminated
- 2005-10-05
- Location
- Utica, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SELECT ONE LAPAROSCOPY ELECTRODE (K960808) | Conmedcorp | 1996-03-21 |