Device recall

Z-1620-2013: Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile…

FDA device recall · Class II · Zimmer, Inc.

Key facts

Recall number (Z-number) Z-1620-2013
Recall event 65301
Product Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Product code LXH
Recalling firm Zimmer, Inc.
Recall class Class II
Status Terminated
Termination date Dec 18, 2014
FEI number 1000220733

At a glance

  • None 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

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