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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm 90 Degree Part Number A133501

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  Class 2 Device Recall 3.5mm 90 Degree Part Number A133501 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-0621-2012
Recall Event ID 60049
510(K)Number K082980  
Product Classification Electrosurgical, cutting ; coagulation ; accessories - Product Code GEI
Product 3.5mm 90 Degree Part Number A1335-01 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 Numbers 0933831-2, 093534102, and 5L14150-A
Recalling Firm/
Manufacturer		 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 Lot Number (QTY): 0933831-2 (3 units), 093534102 (1 unit), and 5L14150-A (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.
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