lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
This recall has been terminated (originally issued January 14, 2015).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- December 19, 2014
- Posted
- January 14, 2015
- Terminated
- January 11, 2016
- Recall Number
- Z-0977-2015
- Quantity
- 4 devices
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including TX, OH, VA, and Washington, DC.
Lot / Code Info
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Root Cause
Device Design
Action Taken
Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.