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Integra® External Fixation System
Ascension Orthopedics, Inc. · Model 12225400 · UDI-DI 10381780125563
KTT
Prescription
1
510(k) clearances
10,126
Adverse events (28 deaths)
89
Recalls
247
Facilities
Description
A rockerbottom is attached to the bottom of the external device so that the patient may stand on it if needed. It is manufactured from aluminum and silicone rubber.
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.