Class IIIOngoingZ-0896-2026
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer Sys…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Orthofix U.S. LLC recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Class IIIOngoingZ-0895-2026
Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catal…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0894-2026
Orthofix U.S. LLC recalls Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0893-2026
Orthofix U.S. LLC recalls Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System M…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0892-2026
Orthofix U.S. LLC recalls Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Cat…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIIOngoingZ-0891-2026
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer S…
Labeling contains claims that are not consistently present.
Orthofix U.S. LLCTXDec 17, 2025
Class IIOngoingZ-0478-2026
Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw
Polyaxial screws do not meet performance standards.
Orthofix U.S. LLCTXNov 19, 2025
Class IIOngoingZ-2555-2025
Orthofix U.S. LLC recalls PILLAR SA Ti
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box.…
Orthofix U.S. LLCTXSep 17, 2025
Class IIOngoingZ-1432-2025
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Orthofix U.S. LLCTXApr 2, 2025