Recall Z-1479-2015 ยท FTY Tape, Measuring, Rulers And Calipers
SpineFrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
| Date | Apr 21, 2015 (initiated Mar 5, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 5 devices |
| Distribution | US Nationwide Distribution in the states of TX, KS, CO, and MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc., Feb 15, 2013 |