Device recall

Z-1411-04: Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No…

FDA device recall · Class II · Biomet, Inc.

Key facts

Recall number (Z-number) Z-1411-04
Recall event 29565
Product Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026.
Product code GEI
Recalling firm Biomet, Inc.
Recall class Class II
Status Terminated
Termination date Oct 5, 2004
510(k) numbers K945765
FEI number 1825034

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)