Z-1411-04

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

Name: Z-1411-04 Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No...
Creator: Biomet, Inc.
Published: 2004-07-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2004-07-12 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026 on 2004-07-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1411-04
Status: Terminated
Initiated: 2004-07-12
Posted: 2004-08-28
Terminated: 2004-10-05
Recalling firm: Zimmer GmbH
Product: Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: packaging
FDA 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 in commerce: 79
Distribution: United States.
Product codes and lots: Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.

Product code GEI

K945765Class IIHigh Temperature CauteryAaron Medical Industries / cleared 1995-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)