FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: Guardian Distal Femur Axial Pin
- Recall number
- Z-1405-04
- Recalling firm
- Wright Medical Technology Inc
- Product
- Guardian Distal Femur Axial Pin
- Status
- Terminated
- Initiated
- 2004-07-14
- Posted
- 2004-08-24
- Terminated
- 2005-07-05
- Reason
- Potential for self -locking axial pin to dislodge and 'back out'.
- Root cause
- Other
- Action
- The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
- Quantity
- 44
- Distribution
- Nationwide. Ontario, and Taiwan, ROC
- Lot, serial or model codes
- Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074
- 510(k) numbers
- ["K013035"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- 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