XTANT Medical
XTANT Medical has 3 FDA enforcement events on this register (3 product records) between 2020 and 2021: 3 device; the busiest year was 2020 with 2.
0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in MT.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 29 Dec 2021 | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. | Device | Class II | 1 | Terminated |
| 30 Sep 2020 | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4,… | Device | Class III | 1 | Terminated |
| 12 May 2020 | Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has XTANT Medical had?
3 enforcement events (3 product records) on this register, 2020–2021: 3 device.
Are any XTANT Medical recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are XTANT Medical recalls?
2 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.