Recall Z-0989-2014— Aesculap, Inc.

Name: FDA recall Z-0989-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-23

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2013-12-23, terminated 2014-10-01. It names one FDA 510(k) clearance: K120559. 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.. Reason: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-23
Terminated: 2014-10-01
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEMAesculap, Inc.·cleared 2012-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

Data sourced from openFDA. This site is unofficial and independent of the FDA.