Recall Z-0827-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Amendia, Inc
Zeus-P Lumbar Interbody Device
| Date | Dec 20, 2016 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect. |
| Root cause | Error in labeling |
| Action | Amendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions please call (404) 610-7215. |
| Quantity | 25 units |
| Distribution | US Distribution to the states of : GA. MI, OK, SC, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151322 | Amendia Interbody Fusion Devices Amendia, Inc., Sep 10, 2015 |