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.
Recall
- Recall Number
- Z-0923-2010
- Event Number
- 54381
- Firm
- Medtronic Navigation, Inc
- FEI Number
- 1000517638
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- November 3, 2009
- Posted
- March 3, 2010
- Terminated
- August 13, 2010
- Address
- 826 Coal Creek Circle, Louisville, CO, 80027-9710
Description
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.
Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.
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.
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.
244 units