The Recall Desk

Manufacturer

New Standard Device Inc

4 recalls in our database name New Standard Device Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2023-06-21

Of the 4 recalls from New Standard Device 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.

1–4 of 4

  • HighFDA (Devices)·Z-1824-2023·2023-06-21

    External Fixation System Post Component Recall Due to Thread Stripping

    New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.

    Product
    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2022·2022-09-07

    Metalogix Self-Drill Half-Pin Surgical Component Recalled for Tip Breakage

    New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.

    Product
    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metal
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1280-2022·2022-06-29

    FDA Recalls Metalogix Slotted 90 Tubular Wrench Due to Manufacturing Error

    New Standard Device Inc is recalling 14 Metalogix Slotted 90 Tubular Wrenches (Lot A29618A) due to a manufacturing error that causes the wrench to strip nuts when torqueing. No injuries have been reported.

    Product
    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1236-2022·2022-06-15

    1.8mm Truss Wire Component Recalled for Product Upgrade

    New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.

    Product
    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
    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.

New Standard Device, LLC

Source: Wikidata (Q140191281), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.