Recall Z-0325-2018 ยท NKB Thoracolumbosacral Pedicle Screw System
Amendia, Inc
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
| Date | Jul 7, 2017 |
| Status | Terminated |
| Reason | Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length. |
| Root cause | Process control |
| Action | Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224. |
| Quantity | 41 screws |
| Distribution | Distribution to Georgia, USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153152 | Syzygy Stabilization System Amendia, Inc., Apr 27, 2016 |