Recall Z-0790-2019 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
XTANT MEDICAL INC
Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASS
| Date | Dec 19, 2018 |
| Status | Terminated |
| Reason | This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration. |
| Root cause | Labeling Change Control |
| Action | The firm, Xtant Medical, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter dated 12/14/2018 on 12/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Complete and return the enclosed tracking/ve |
| Quantity | 632 units |
| Distribution | US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170119 | Calix Lumbar Spinal Implant System X-Spine Systems, Inc., Sep 29, 2017 |