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Integra® External Fixation System
Ascension Orthopedics, Inc. · Model 12224216 · UDI-DI 10381780125136
KTT
Prescription
1
510(k) clearances
9,903
Adverse events (28 deaths)
89
Recalls
246
Facilities
Description
The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
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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Get your free API keyRead the docsData 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.