—#88355

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K021980
Affected lot / code info: All lot numbers.

Why it was recalled

Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc
Address: 826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-11-03
Posted by FDA: 2010-03-03
Terminated: 2010-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.