PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
FDA device recall Z-0624-2014 · posted 2014-01-03 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
- Action taken
- On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HXB
- Quantity affected
- 13 devices
- Distribution
- US Distribution: including states of: TX and VA.
- Date initiated
- 2013-09-11
- Date posted
- 2014-01-03
- Date terminated
- 2014-10-08
- 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 |
|---|---|---|
| SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K123164) | Spinefrontier, Inc. | 2013-02-15 |