Recall Z-1440-2021 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medtronic Sofamor Danek USA, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination there
| Date | Mar 17, 2021 |
| Status | Terminated |
| Reason | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. |
| Root cause | Packaging process control |
| Action | The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device. |
| Quantity | 11 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Titan Spine, LLC, Oct 27, 2014 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion D Titan Spine, Inc., Feb 11, 2019 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Titan Spine, Inc., Aug 16, 2019 |