Date Initiated by Firm |
August 08, 2011 |
Date Posted |
January 11, 2012 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number |
Z-0614-2012 |
Recall Event ID |
60049 |
510(K)Number |
K101448
|
Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
|
Product |
OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor
Intended to be used for fixation of soft tissue to bones |
Code Information |
Lot Number 1004579 |
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 |
7 Units |
Distribution |
Nationwide Distribution including Texas |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
510(K) Database |
510(K)s with Product Code = MBI and Original Applicant = ARTHROCARE CORP.
|