FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0923-2010
- Recalling firm
- Medtronic Navigation, Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-11-03
- Posted
- 2010-03-03
- Terminated
- 2010-08-13
- 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 Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK.
- Lot, serial or model codes
- All lot numbers.
- 510(k) numbers
- ["K021980"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28