Z-0989-2014Class II

Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut...

Name: Z-0989-2014 Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut...
Creator: Aesculap, Inc.
Published: 2013-12-23
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-12-23 / Terminated / root cause: manufacturing process

FDA source

Aesculap, Inc. began a recall of Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of... on 2013-12-23. FDA classified it as Class II and gives the reason as "The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0989-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-23
Posted: 2014-02-19
Terminated: 2014-10-01
Recalling firm: Aesculap Inc
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 Shunt, Central Nervous System And Components
Reason for recall: The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Aesculap sent an Important Correction and Removal Notification dated December 23, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.. Yom"Aesculap Sales Representative will contact you to schedule a time to remove the FV795T from Set FV792T. Please use FV790T in the absence of the FV795T to ensure the correct adjustment has been made. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please call (610) 984-9265 or (610) 984-9414 with any questions.
Quantity in commerce: 79
Distribution: Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
Product codes and lots: 4 lots: 4505268906, 4505336973, 4505408485, 4505238953

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0989-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0989-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19

Product code JXG

K120559Class IIAesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)