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External Fixator Connection 15/15

GEXFIX SA · Model 1010-1000 · UDI-DI 07640136270002

KTT Prescription

510(k) clearances

10,126

Adverse events (28 deaths)

Recalls

246

Facilities

Description

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Recalls

Date	Firm	Reason
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01	Stryker GmbH	Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-06-10	Orthofix U.S. LLC	Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
2026-06-10	Orthofix U.S. LLC	Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
2026-06-10	Orthofix U.S. LLC	Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.