Date Initiated by Firm | August 08, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number | Z-0612-2012 |
Recall Event ID |
60049 |
510(K)Number | K070671 |
Product Classification |
Endoscope and/or accessories - Product Code KOG
|
Product | OPUS SmartStitch Product Number OM-8178 is a suture cartridge
For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. |
Code Information |
Lot Number 121748 |
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 | 18 units |
Distribution | Nationwide Distribution including Texas |
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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.
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510(K) Database | 510(K)s with Product Code = KOG
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