FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Recall number
- Z-0809-2018
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
- Status
- Terminated
- Initiated
- 2017-09-21
- Posted
- not on file
- Terminated
- 2018-08-08
- Reason
- A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
- 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
- 2
- Distribution
- US Distribution to PA.
- Lot, serial or model codes
- Batch #20034364 and #20034751
- 510(k) numbers
- ["K161853"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28