Class 2 Device Recall OPUS SpeedScrew Implant Product Number OM6500

• Date Initiated by Firm: August 08, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated 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: 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

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