Class II — XTANT MEDICAL INC
| Recalling firm | Xtant Medical Holdings, Inc. |
|---|---|
| Registered facility | Xtant Medical Holdings, Inc. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | 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 ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TL… |
| 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. |
| Initiated | 2018-12-19 |
| Classified | 2019-01-30 |
| Terminated | 2021-04-01 |
| Recall number | Z-0790-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — XTANT MEDICAL INC (Z-0790-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81899/
Alerts for Xtant Medical Holdings, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.