Recall Z-2502-2020 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
CTL Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
| Date | Aug 21, 2019 |
| Status | Completed |
| Reason | Reports received of the device fracturing during insertion. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated 8/21/2019 to all distributors or CTL representatives via email beginning 8/21/2019 with a follow-up hard copy of the correspondence being issued via FedEx. The devices were to be returned. |
| Quantity | 39 units |
| Distribution | Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131981 | CEZANNE II INTERBODY FUSION SYSTEM Accel Spine, Oct 9, 2013 |