ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as follows: Cat. #60-5158-027 - Spatula 5
FDA device recall Z-1412-04 · posted 2004-08-28 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- 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.
- Action taken
- Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 5,467 units
- Distribution
- 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, Pe
- Date initiated
- 2004-08-09
- Date posted
- 2004-08-28
- Date terminated
- 2005-10-05
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED SELECT ONE LAPAROSCOPY ELECTRODE (K960808) | Conmedcorp | 1996-03-21 |