FDA Medical Device Recalls (openFDA)
Ascension Orthopedics, Inc: Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.
- Recall number
- Z-1524-2009
- Recalling firm
- Ascension Orthopedics, Inc
- Product
- Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.
- Status
- Terminated
- Initiated
- 2009-04-14
- Posted
- 2009-06-26
- Terminated
- 2010-09-24
- Reason
- Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.
- Root cause
- Pending
- Action
- Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.
- Quantity
- 9 units.
- Distribution
- Nationwide Distribution -- including states of CO, OR, and TX.
- Lot, serial or model codes
- Lot #145B08
- 510(k) numbers
- ["K022324","K022325"]
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 3002788818
- Firm city
- Austin
- Firm state
- TX
- 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