—#34120

Product

Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K945765
Affected lot / code info: Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: United States.

Timeline

Recall initiated: 2004-07-12
Posted by FDA: 2004-08-28
Terminated: 2004-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.