Recall Z-0212-2020 ยท HWC Screw, Fixation, Bone
CrossRoads Extremity Systems, LLC
MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
| Date | Sep 19, 2019 |
| Status | Terminated |
| Reason | Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. |
| Root cause | Labeling mix-ups |
| Action | CrossRoads Extremity Systems notified customers on about 09/19/2019 via email. The email informed customers that pack-out potentially includes a 3.0mm x 30mm screw instead of 3.0 x 28mm screw. Instructions included to return all affected screws to CrossRoads Extremity Solutions immediately with provided label and return materials authorization. |
| Quantity | 36 screws |
| Distribution | Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173710 | MotoBAND CP Implant System Crossroads Extremity Systems, LLC, Feb 12, 2018 |