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U.S. Department of Health and Human Services

Class 2 Device Recall OPUS Magnum 2 Plus Implant Product Number OM1502

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  Class 2 Device Recall OPUS Magnum 2 Plus Implant Product Number OM1502 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-0608-2012
Recall Event ID 60049
510(K)Number K083240  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor

Intended for rotator cuff repair in the shoulder.
Code Information Lot Numbers 120761, 120570, 120760, 120010, 1191150, and 120755
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): 120761 (7 units), 120570 (6 units), 120760 (5 units), 120010 (1 units), 1191150 (1 units), and 120755 (24 units)
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 = ARTHROCARE CORP.
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