Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall proSA Tool Set (Model: FV92T)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall proSA Tool Set (Model: FV92T) see related information
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.
-
-