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.
- Company
- Ascension Orthopedics, Inc
- Recall Initiated
- April 14, 2009
- Posted
- June 26, 2009
- Terminated
- September 24, 2010
- Recall Number
- Z-1524-2009
- Quantity
- 9 units.
- Firm Location
- Austin, TX
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.
Distribution
Nationwide Distribution -- including states of CO, OR, and TX.
Lot / Code Info
Lot #145B08
Root Cause
Pending
Action Taken
Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.
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