Recall Z-0809-2018 ยท JXG Shunt, Central Nervous System And Components
Aesculap Implant Systems LLC
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
| Date | Sep 21, 2017 |
| Status | Terminated |
| 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 |
| Quantity | 2 |
| Distribution | US Distribution to PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System Aesculap, Inc., Feb 27, 2017 |