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Integra® External Fixation System
Ascension Orthopedics, Inc. · Model 12224240 · UDI-DI 10381780125341
KTT
Prescription
1
510(k) clearances
10,126
Adverse events (28 deaths)
89
Recalls
246
Facilities
Description
The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
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.