• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 90 Degree LoPro with Cable Part Number AC133601

  • 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 90 Degree LoPro with Cable Part Number AC133601 see related information
Date Initiated by Firm August 08, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 27, 2012
Recall Number Z-0625-2012
Recall Event ID 60049
510(K)Number K082980  
Product Classification Electrosurgical, cutting ; coagulation ; accessories - Product Code GEI
Product 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand

Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Code Information Lot Number Q732460-A
Recalling Firm/
Innovatech Medical Resources L.P.
5455 Honeysuckle Road
Midlothian TX 76065
Manufacturer Reason
for Recall
Product is being removed from the field due to an over-label issue.
FDA Determined
Cause 2
Reprocessing Controls
Action Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution including Texas
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 = GEI and Original Applicant = ARTHROCARE CORP.