Recall Z-2070-2015 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Exactech, Inc.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or
| Date | Jul 14, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| Reason | Shipped to a single consignee prior to completion of final inspection. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered. |
| Quantity | 4 devices. |
| Distribution | Nationwide Distribution to Florida only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142576 | Spinal System Eisertech, LLC, Feb 26, 2015 |