FDA Medical Device Recalls (openFDA)
Medtronic Surgical Navigation Tech, Inc: Fix pins associated with Stealth Station Treatment Guidance Platform
- Recall number
- Z-0231-04
- Recalling firm
- Medtronic Surgical Navigation Tech, Inc
- Product
- Fix pins associated with Stealth Station Treatment Guidance Platform
- Status
- Terminated
- Initiated
- 2003-10-31
- Posted
- 2003-12-17
- Terminated
- 2003-12-19
- Reason
- Surgical devices intended for single use were not labeled for single use.
- Root cause
- Other
- Action
- Consignees were notified by letter on 11/01/2003.
- Quantity
- 127 devices
- Distribution
- Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.
- Lot, serial or model codes
- 3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.
- 510(k) numbers
- ["K021980","K030552","K001153","K012937"]
- 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