FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: Guardian Distal Femur Axial Pin
- Recall number
- Z-0523-06
- Recalling firm
- Wright Medical Technology Inc
- Product
- Guardian Distal Femur Axial Pin
- Status
- Terminated
- Initiated
- 2006-01-03
- Posted
- 2006-02-16
- Terminated
- 2007-01-29
- Reason
- The product was not fully assembled prior to packaging.
- Root cause
- Other
- Action
- The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.
- Quantity
- 10
- Distribution
- Nationwide and PR
- Lot, serial or model codes
- Lot Nos. 75258083 and 7521663501
- 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