Recall Z-0127-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
X Spine Systems Inc
Calix T PEEK Lumbar System, TLIF Trial
| Date | May 17, 2016 |
| Status | Terminated |
| Reason | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
| Root cause | Component design/selection |
| Action | Consignees will be notified via email and courier and will be instructed to return the affected product. Upon receipt of the recalled trays, the trials and rasps will be removed from the tray and quarantined for evenutal destruction. |
| Quantity | 1186 units |
| Distribution | Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM X-Spine Systems, Inc., Oct 23, 2013 |