Recall Z-1234-2020 ยท NKB Thoracolumbosacral Pedicle Screw System
Medicrea International
Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
| Date | Nov 11, 2019 |
| Status | Terminated |
| Reason | Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) |
| Root cause | Device Design |
| Action | Medicrea issued notification dated 11/11/19 via email, stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. contact person for this action is given below: Karine TROGNEUX-MEDICRE |
| Quantity | 3 units |
| Distribution | CA, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190376 | PASS LP Spinal System Medicrea International SA, May 2, 2019 |