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Integra® External Fixation System

Ascension Orthopedics, Inc. · Model 12225210 · UDI-DI 10381780125419

KTT Prescription

510(k) clearances

10,126

Adverse events (28 deaths)

Recalls

249

Facilities

Description

The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features one distal end which is designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.

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.