Recall Z-0082-2019 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
| Date | Jul 12, 2018 |
| Status | Terminated |
| Reason | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Root cause | Under Investigation by firm |
| Action | Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018. |
| Quantity | 41 devices |
| Distribution | Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180459 | VERASENSE for Zimmer Biomet Persona Orthosensor, Inc., Jun 7, 2018 |