Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera
FDA device recall Z-0923-2010 · posted 2010-03-03 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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, I
- Date initiated
- 2009-11-03
- Date posted
- 2010-03-03
- Date terminated
- 2010-08-13
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIP MODULE FOR THE STEALTHSTATION SYSTEM (K021980) | Medtronic Surgical Navigation Technologies | 2002-11-19 |