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Terminated

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

FDA Recall Z-1411-04 · Posted 2004-08-28

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2004-07-12
Date Terminated2004-10-05
Product Quantity79

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.

Firm 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.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945765HIGH TEMPERATURE CAUTERYAaron Medical Industries · 1995-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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