Z-0809-2018Class II

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and...

Name: Z-0809-2018 proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and...
Creator: Aesculap Implant Systems LLC
Published: 2017-09-21
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-09-21 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components on 2017-09-21. FDA classified it as Class II and gives the reason as "A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure". 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-0809-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-21
Posted: 2018-03-01
Terminated: 2018-08-08
Recalling firm: Aesculap Inc
Product: proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 2
Distribution: US Distribution to PA.
Product codes and lots: Batch #20034364 and #20034751

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code JXG

K161853Class IIproGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt SystemAesculap, Inc. / cleared 2017-02-27

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)