Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245,
FDA device recall Z-0074-2008 · posted 2007-12-13 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
- Action taken
- Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution - USA, The Netherlands, Australia, and Canada.
- Date initiated
- 2007-08-24
- Date posted
- 2007-12-13
- Date terminated
- 2009-08-21
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TSRH SPINAL SYSTEM (K052144) | Medtronic Sofamor Danek | 2005-08-31 |