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 Endoscopic Tarsal Tunnel Decompression

  • 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 Endoscopic Tarsal Tunnel Decompressionsee related information
Date Initiated by FirmNovember 24, 2015
Date PostedDecember 22, 2015
Recall Status1 Terminated 3 on June 27, 2016
Recall NumberZ-0469-2016
Recall Event ID 72748
Product Classification Arthroscopic surgery component - Product Code HRX
ProductHook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Code Information Lot number MDHZ620
FEI Number 1000118334
Recalling Firm/
Manufacturer		 Instratek, Incorporated
15200 Middlebrook Dr Ste G
Houston TX 77058-1217
For Additional Information ContactJeff Seavey
281-890-8020
Manufacturer Reason
for Recall		The sterile blade will not fit into the handle provided with the ETTD system.
FDA Determined
Cause 2		Employee error
ActionInstratek contacted customers by phone call either by direct contact or voice mail message on November 23, 2015. that a recall was being initiated. Formal letters were sent via UPS to the Customers annoucing the recall on November 24, 2015. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product,please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You should contact lnstratek's Customer service for a return authorization number and further instructions for return of unused product.
Quantity in Commerce39 units
DistributionUS distribution to the states: TX, UT, NY and CO.
Total Product Life CycleTPLC 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.
-
-