The Recall Desk

Manufacturer

XTANT MEDICAL INC

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2020-03-25

Of the 3 recalls from XTANT MEDICAL INC 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

  • ModerateFDA (Devices)·Z-1526-2020·2020-03-25

    XTANT Medical Recalls OsteoSelect DBM Putty Due to Volume Discrepancy

    XTANT Medical is recalling 26 units of OsteoSelect DBM Putty because three devices contained 5.0cc instead of the labeled 10.0cc.

    Product
    OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2019·2019-02-06

    XTant Medical Recalls Calix Lumbar Spinal Implants for Sterilization Concerns

    XTant Medical is recalling 632 Calix Lumbar Spinal Implant System units due to a change in packaging and sterilization method to address potential risks of compromised sterilization.

    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 X034-0242P
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1884-2017·2017-05-03

    XTANT Medical Recalls 5.5mm CoCr Straight Rods Due to Labeling Error

    XTANT Medical Inc. is recalling 97 units of 5.5mm CoCr Straight Rods because the labels may incorrectly identify the material as Ti6Al-4V ELI instead of Cobalt Chromium.

    Product
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected betwe
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.