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U.S. Department of Health and Human Services

Class 2 Device Recall Saber 30 Part Number A433001

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 Class 2 Device Recall Saber 30 Part Number A433001see related information
Date Initiated by FirmAugust 08, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on September 27, 2012
Recall NumberZ-0622-2012
Recall Event ID 60049
510(K)NumberK082980 
Product Classification Electrosurgical, cutting ; coagulation ; accessories - Product Code GEI
ProductSaber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Code Information Lot Numbers 2711631, 2715201, and 2726711
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
ActionInnovatech 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 CommerceLot Number (QTY): 2711631 (1 unit), 2715201 (1 unit), and 2726711 (1 unit)
DistributionNationwide Distribution including Texas
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.
510(K) Database510(K)s with Product Code = GEI
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