The FDA has posted 12 enforcement recalls of multiple component nail/blade/plate combination fixation appliance devices since 2025, none of them Class I (most serious). Most recent report: Aug 5, 2026.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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
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
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
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
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component”). Informational only — verify against the FDA before acting.