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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ascension Orthopedics, Inc
Lot Codes / Batch Numbers
Lot #145B08
Products Sold
Lot #145B08
Ascension Orthopedics, Inc is recalling Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; due to Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or strippin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026