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.
FDA Recall Z-0989-2014 · Posted 2014-02-19
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJXG
Date Initiated2013-12-23
Date Terminated2014-10-01
Product Quantity79
Reason for Recall
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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