Recall Z-1479-2015
SpineFrontier, Inc. · initiated March 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Revision E
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.
FDA-determined cause: Labeling 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.
Details
- Recall number
- Z-1479-2015
- Initiated
- March 5, 2015
- Posted by FDA
- April 21, 2015
- Terminated
- June 15, 2015
- Product code
- FTY – Tape, Measuring, Rulers And Calipers
- Quantity
- 5 devices
- Distribution
- US Nationwide Distribution in the states of TX, KS, CO, and MA
- Recalling firm
- SpineFrontier, Inc., Beverly, MA