Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascen
FDA device recall Z-1524-2009 · posted 2009-06-26 · Terminated
Recall details
- Recalling firm
- Ascension Orthopedics, Inc
- 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.
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 9 units.
- Distribution
- Nationwide Distribution -- including states of CO, OR, and TX.
- Date initiated
- 2009-04-14
- Date posted
- 2009-06-26
- Date terminated
- 2010-09-24
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM (K022324) | Osteomedics, Inc. | 2002-09-17 |
| NORMED TITANIUM OSTEOTOMY PLATING SYSTEM (K022325) | Osteomedics, Inc. | 2002-09-09 |