Orthofix U.S recalls

5 official recalls and safety alerts involving Orthofix U.S since 2025-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Orthofix U.S or the relevant agency.

1. 2026-07-22
2. US
   Drugs & medicalClass II

   Orthofix U.S. LLC recalls 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

   FDA · DeviceOrthofix U.S. LLCUS: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA…Official notice →
3. 2025-12-17
4. US
   Drugs & medicalClass III

   Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿,…

   Labeling contains claims that are not consistently present.

   FDA · DeviceOrthofix U.S. LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
5. 2025-11-19
6. US
   Drugs & medicalClass II

   Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW,…

   Polyaxial screws do not meet performance standards.

   FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, North Carolina, and…Official notice →
7. 2025-09-17
8. US
   Drugs & medicalClass II

   Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

   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. The 37 mm width on the…

   FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of CO, CA.Official notice →
9. 2025-04-02
10. US
    Drugs & medicalClass II

    Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP,…

    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.

    FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, Colorado, and Missouri.Official notice →