Recall Z-0977-2015
SpineFrontier, Inc. · initiated December 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Codes / lots: Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
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.
FDA-determined 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.
Details
- Recall number
- Z-0977-2015
- Initiated
- December 19, 2014
- Posted by FDA
- January 14, 2015
- Terminated
- January 11, 2016
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 4 devices
- Distribution
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA