The Recall Desk

Manufacturer

Instratek, Incorporated

3 recalls in our database name Instratek, Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2015-12-30

Of the 3 recalls from Instratek, Incorporated 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-0469-2016·2015-12-30

    Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression

    Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.

    Product
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2679-2014·2014-10-01

    Instratek Recalls Mini Screw Sets with Faded Markings

    Instratek is recalling 96 Mini Screw Sets and gauges due to faded and incorrect markings on instruments.

    Product
    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0922-2013·2013-03-20

    Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues

    Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.

    Product
    Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide