SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a
FDA device recall Z-1479-2015 · posted 2015-04-21 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
- Action taken
- SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- FTY
- Quantity affected
- 5 devices
- Distribution
- US Nationwide Distribution in the states of TX, KS, CO, and MA
- Date initiated
- 2015-03-05
- Date posted
- 2015-04-21
- Date terminated
- 2015-06-15
- 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 |