KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mecha
FDA device recall Z-1737-2013 · posted 2013-07-16 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
- Action taken
- SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 2 rods
- Distribution
- USA Nationwide Distribution including the state of TX
- Date initiated
- 2011-12-30
- Date posted
- 2013-07-16
- Date terminated
- 2014-01-08
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KRD1 PEDICLE SCREW SYSTEM (K092420) | Spinefrontier, Inc. | 2009-11-19 |