| Class 2 Device Recall Orthopedic Dovetail Clamp | |
Date Initiated by Firm | November 03, 2009 |
Date Posted | March 03, 2010 |
Recall Status1 |
Terminated 3 on August 13, 2010 |
Recall Number | Z-0923-2010 |
Recall Event ID |
54381 |
510(K)Number | K021980 |
Product Classification |
Neurological Stereotaxic Instrument - Product Code HAW
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Product | Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027.
In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery. |
Code Information |
All lot numbers. |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc 826 Coal Creek Circle Louisville CO 80027-9710
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For Additional Information Contact | 720-890-3200 |
Manufacturer Reason for Recall | Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed. |
FDA Determined Cause 2 | Error in labeling |
Action | All affected users were notified by a Product Correction Notification letter on 11/03/2009 providing a description of the issue and informing them of the updated instructions for use for the Orthopedic Dovetail Clamp. Customers are to ensure that all users read the letter, place a copy of the letter with the IFUs for the related software applications listed in the letter, and fill out the attached response form indicating the receipt of the information. Further information is available at 720-890-3309. |
Quantity in Commerce | 244 units |
Distribution | Worldwide Distribution -- USA, including VA, IA, MN and OK and countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Iceland, India, Israel, Italy, Japan, Korea, Lebanon, Malta, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK. |
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.
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510(K) Database | 510(K)s with Product Code = HAW
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