The Recall Desk

Manufacturer

Extremity Medical LLC

4 recalls in our database name Extremity Medical LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2013-03-27

Of the 4 recalls from Extremity Medical LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) 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-0952-2013·2013-03-27

    Extremity Medical Recalls Undersized 1.6 mm Orthopedic Guidewires

    Extremity Medical LLC is recalling 238 non-sterile 1.6 mm guidewires because they are undersized, causing depth gauge readings to select screws approximately 2 mm longer than intended.

    Product
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriat
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0752-2013·2013-02-06

    Extremity Medical Recalls IO FiX System Screw Measuring Device

    Extremity Medical LLC is recalling 93 units of the IO FiX System Accessory screw measuring device because it may measure screw length approximately 5 mm short, potentially leading to the selection of an inappropriate implant size.

    Product
    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0438-2013·2012-12-05

    Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage

    Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.

    Product
    IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0344-2013·2012-11-28

    Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure

    Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.

    Product
    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and
    Category
    Medical Device
    Distribution
    Distributed nationwide