proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
FDA Recall Z-0809-2018 · Posted None
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Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeJXG
Date Initiated2017-09-21
Date Terminated2018-08-08
Product Quantity2
Reason for Recall
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Firm Action
Aesculap sent an Urgent Medical Device Recall Notification letter dated September 21, 2017.
1. Review the Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately quarantine the unit.
2. Determine the current inventory of the affected lot(s) within your facility. Please quarantine the product and do use. Do not destroy any affected product. A Sales Representative will come to your facility and remove the affected sets and provide you replacements.
3. Please complete the attached Product Recall Acknowledgement Response Form on the next page of this letter and record the total number of units in your possession. If you have no inventory remaining, please enter zero (0) on the form and reason WHY. The Sales Representative will return the form along with the affected product to:
4.The Sales Representative will contact Customer Service to order replacements sets and get a Recall RGR number to return the affected sets.
For further questions, please call (610) 984-9414 Ext. 5414
Root Cause
Process control
Distribution Pattern
US Distribution to PA.
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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