Recall Z-0923-2010 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
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.
| Date | Mar 3, 2010 (initiated Nov 3, 2009) |
| Status | Terminated |
| Reason | Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed. |
| Root cause | 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 | 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 Fe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies, Nov 19, 2002 |