Device recall

Z-0989-2014: Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt…

FDA device recall · Class II · Aesculap, Inc.

Key facts

Recall number (Z-number) Z-0989-2014
Recall event 67174
Product Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Product code JXG
Recalling firm Aesculap, Inc.
Recall class Class II
Status Terminated
Termination date Oct 1, 2014
510(k) numbers K120559
FEI number 2916714

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

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