Recall Z-0777-2020 · HWC Screw, Fixation, Bone
Nextremity Solutions
Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
| Date | Nov 11, 2019 |
| Status | Terminated |
| Reason | Components 2mm shorter than indicated on the package label |
| Root cause | Packaging process control |
| Action | Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F. |
| Quantity | 86 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182201 | Stratum™ Foot Plating System Nextremity Solutions, Inc., Nov 16, 2018 |