Recall Z-1126-2019 · LXL
ulrich medical USA Inc
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
| Date | Mar 8, 2019 |
| Status | Terminated |
| Reason | Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. |
| Root cause | Storage |
| Action | On March 13 , 2019 the firm sent letters to their consignees stating the following: The purpose of this letter is to advise you that ulrich medical USA is voluntarily recalling certain Torque Limiting Handles. Reason for the voluntary recall: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. The calibration issue experienced to date has been limited to select instruments and not all of these instruments have been affected. Due to the nature of how these instruments are used the risk to the patient is low. No injury or death has been reported. Risk to hea |
| Quantity | 25 |
| Distribution | AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX. |
| FDA record | Open on fda.gov |