Recall Z-1524-2009 ยท HXX Screwdriver
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.
| Date | Jun 26, 2009 (initiated Apr 14, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |