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U.S. Department of Health and Human Services

Class 2 Device Recall 5.0 mm Parafix Part Number 225011

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  Class 2 Device Recall 5.0 mm Parafix Part Number 225011 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-0627-2012
Recall Event ID 60049
510(K)Number K042584  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal

Intended for rotator cuff repair.
Code Information Lot Number 205091
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 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 = MBI and Original Applicant = OPUS MEDICAL, INC.
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