Device recall

Z-1552-2010: Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System…

FDA device recall · Class II · Acumed LLC

Key facts

Recall number (Z-number) Z-1552-2010
Recall event 49383
Product Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Product code HSB
Recalling firm Acumed LLC
Recall class Class II
Status Terminated
Termination date May 14, 2010
510(k) numbers K031438
FEI number 1000125930

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)