Recall Z-0203-2016 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Biomet Spine, LLC
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
| Date | Nov 3, 2015 (initiated Sep 29, 2015) |
| Status | Terminated |
| Reason | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet Spine sent an Urgent Medical Device Recall Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has already been implanted, written confirmation of this will be required and the necessary parties will be contacted. They will store returned product in quarantine in an isolated location until they can undergo inspection to verify if they are conforming or not and then will be destroyed or retained. Necessary parts will be destroyed so that it is visually obvious t |
| Quantity | 17 units |
| Distribution | US Distribution to the states of : NY, MO, and FL |
| FDA record | Open on fda.gov |