Recall Z-1029-2015 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
Orthosensor, Inc.
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
| Date | Jan 29, 2015 (initiated Dec 5, 2014) |
| Status | Terminated |
| Reason | Presence of one inoperable (dead) sensor pad. |
| Root cause | Under Investigation by firm |
| Action | OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these device |
| Quantity | 22 devices |
| Distribution | US Distribution to the states of : IL, MI, NY, CA, VA and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130380 | ORTHOSENSOR KNEE BALANCER Orthosensor, Inc., Jun 13, 2013 |