Recall Z-0828-2020 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medicrea International
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
| Date | Sep 16, 2019 |
| Status | Open, Classified |
| Reason | Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded |
| Root cause | Process control |
| Action | Medicrea International issued letter dated 9/12/19 to US Distributor stating reason for recall, health risk and action to take: 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 organisations. Please inform MEDICREA of any adverse events concerning the use of the subject devices 2. Please comply with any local laws or regulations concerning the notification of adverseevents to y |
| Quantity | 190 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190376 | PASS LP Spinal System Medicrea International SA, May 2, 2019 |