Recall Z-1156-2020 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medicrea International
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
| Date | Oct 2, 2019 |
| Status | Terminated |
| Reason | Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter |
| Root cause | Process control |
| Action | Medicrea Issued Voluntary Product Recall dated 10/3/19 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 USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA 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: Tim Huntingt |
| Quantity | 14 units |
| Distribution | OH, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163595 | IMPIX 3D Print Cages Medicrea International SA, Nov 13, 2017 |