Recall Z-1411-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Biomet, Inc.
Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
| Date | Aug 28, 2004 (initiated Jul 12, 2004) |
| Status | Terminated |
| Reason | The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch. |
| Root cause | Other |
| Action | Consignees were notified to inspect the devices for the defect via letter dated and faxed 7/12/04. A second letter issued 7/15/04 instructing consignees NOT to inspect the product, but to return all units. |
| Quantity | 79 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945765 | HIGH TEMPERATURE CAUTERY Aaron Medical Industries, Jan 30, 1995 |