Recall Z-0977-2015— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2014-12-19, terminated 2016-01-11. FDA's recall record names no specific 510(k) clearance for this event. Product: lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164. Reason: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument..
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2016-01-11
- Firm location
- Beverly, MA, United States
Product description
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Reason for recall
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.