Recall Z-0605-2019 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Howmedica Osteonics Corp.
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
| Date | Nov 28, 2018 |
| Status | Terminated |
| Reason | The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction letters were sent to customers on 11/28/18. |
| Quantity | 28,461 |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152304 | Tritanium PL Cage Stryker, Nov 19, 2015 |