Z-1524-2009

Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268...

Name: Z-1524-2009 Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268...
Creator: Ascension Orthopedics, Inc
Published: 2009-04-14
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2009-04-14 / Terminated / root cause: manufacturing process

FDA source

Ascension Orthopedics, Inc began a recall of Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX... on 2009-04-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1524-2009
Status: Terminated
Initiated: 2009-04-14
Posted: 2009-06-26
Terminated: 2010-09-24
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.
Product code: HXX Screwdriver
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 9 units.
Distribution: Nationwide Distribution -- including states of CO, OR, and TX.
Product codes and lots: Lot #145B08

Product code HXX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)