The Recall Desk

Manufacturer

XTANT Medical

3 recalls in our database name XTANT Medical as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2022-02-09

Of the 3 recalls from XTANT Medical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0533-2022·2022-02-09

    Spinal Fusion Implant Insert Recalled for Assembly Defect

    XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.

    Product
    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0429-2021·2020-11-18

    XTANT Medical Recalls Cervical Implants Due to Incorrect Titanium Grade Labeling

    XTANT Medical is recalling 508 units of cervical implants because the labels incorrectly identify the grade of titanium used in the devices.

    Product
    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 Numb
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2500-2020·2020-07-15

    XTANT Medical Recalls Irix-C Forceps Inserter Due to Fracture Risk

    XTANT Medical is recalling four Irix-C Forceps Inserters because the strike plate may fracture off due to unsatisfactory welds.

    Product
    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
    Category
    Medical Device
    Distribution
    3 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Xtant Medical (United States)

company in Belgrade, United States

Country
United States
Founded
2006

Official website

Source: Wikidata (Q106411859), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.