FDA Medical Device Recalls (openFDA)
Stryker Instruments, Instruments Div.: Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
- Recall number
- Z-0020-05
- Recalling firm
- Stryker Instruments, Instruments Div.
- Product
- Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
- Status
- Terminated
- Initiated
- 2004-07-14
- Posted
- 2004-10-19
- Terminated
- 2004-10-18
- Reason
- The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
- Root cause
- Other
- Action
- Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.
- Quantity
- not on file
- Distribution
- United States.
- Lot, serial or model codes
- Serial numbers PG04-0001 through PG04-0017.
- 510(k) numbers
- ["K022365"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- 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