Recall Z-0891-2017 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Amendia, Inc
Optimus Fixed Awl
| Date | Dec 22, 2016 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | Complaints that the tip of the awl broke after impaction during surgery. |
| Root cause | Device Design |
| Action | Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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 | 9 devices |
| Distribution | US Distribution to the states of : FL, GA. IL, MO, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132596 | PROPOSED OPTIMUS Custom Spine, Inc., Apr 11, 2014 |