Recall Z-0989-2014 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
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.
| Date | Feb 19, 2014 (initiated Dec 23, 2013) |
| Status | Terminated |
| Reason | The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120559 | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM Aesculap, Inc., May 24, 2012 |