Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
FDA adverse event reports and recall history for appliance, fixation, nail/blade/plate combination, multiple component (product code KTT), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 9,903
- Deaths
- 28
- Injuries
- 7,108
- Malfunctions
- 2,735
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-29Open, ClassifiedDevice Design
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- 2026-07-14Open, ClassifiedProcess change control
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
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
- 2026-07-14Open, ClassifiedProcess change control
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
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
- 2026-07-14Open, ClassifiedProcess change control
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
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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DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.