Biomet, Inc. Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.
Products Sold
Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.
Biomet, Inc. is recalling Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026