Recall Z-2854-2020 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8
| Date | Aug 22, 2020 (initiated Jul 22, 2020) |
| Status | Terminated |
| Reason | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. |
| Root cause | Nonconforming Material/Component |
| Action | A customer letter dated July 22, 2020 was mailed to customers. In this letter customers are instructed to immediately examine their inventory and determine if they have any of the affected implants. Alternatively, they may return all ALTERA inventory and Globus will sort out the affected implants and replace inventory with conforming implants. Report any adverse effects believed to be associated with the product to Globus Medical immediately by filling out the attached Response Card. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140411 | ALTERA SPACER Globus Medical, Inc., Jul 1, 2014 |