Recall Z-0954-2023 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
CoreLink LLC
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
| Date | Jan 12, 2023 (initiated Oct 20, 2022) |
| Status | Terminated |
| Reason | Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy. |
| Root cause | Process control |
| Action | CoreLink initiated their recall by telephone to the physicians on 10/20/2022. The firm followed with a letter sent by FedEx. The letter explained the problem and the potential risk for health: "Potential Risks to Health: Please be aware that our records indicate your practice may have used one or more of the affected AT3208 devices (as shown in the table above), and that patients implanted with a FLXfit Expandable Interbody Spacer from affected lots should be monitored for: 1. MRI Safety: FLXfit devices, per current labeling, are not approved in the MR environment, and additionally, this l |
| Quantity | 18 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171519 | FLXfit Expanding Orthopedics, Inc., Sep 15, 2017 |