Date Initiated by Firm |
September 21, 2017 |
Create Date |
March 01, 2018 |
Recall Status1 |
Terminated 3 on August 08, 2018 |
Recall Number |
Z-0809-2018 |
Recall Event ID |
79093 |
510(K)Number |
K161853
|
Product Classification |
Shunt, central nervous system and components - Product Code JXG
|
Product |
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System
Shunt, central nervous system and components |
Code Information |
Batch #20034364 and #20034751 |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
|
For Additional Information Contact |
Val Strawn 610-984-9414 Ext. 5414
|
Manufacturer Reason for Recall |
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JXG and Original Applicant = AESCULAP INC.
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