Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
FDA device recall Z-1411-04 · posted 2004-08-28 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 79
- Distribution
- United States.
- Date initiated
- 2004-07-12
- Date posted
- 2004-08-28
- Date terminated
- 2004-10-05
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIGH TEMPERATURE CAUTERY (K945765) | Aaron Medical Industries | 1995-01-30 |