Recall Z-0977-2015 ยท LXH Orthopedic Manual Surgical Instrument
SpineFrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
| Date | Jan 14, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 4 devices |
| Distribution | Nationwide Distribution including TX, OH, VA, and Washington, DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.