Device recall

Z-1948-2011: DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy…

FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.

Key facts

Recall number (Z-number) Z-1948-2011
Recall event 57385
Product DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
Product code HBX
Recalling firm DePuy Mitek, Inc., a Johnson & Johnson Co.
Recall class Class II
Status Terminated
Termination date Apr 2, 2013
510(k) numbers K951843
FEI number 1221934

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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