Every recall we track for Orthofix U.S. LLC — 13 in all — plus the complaints and injury reports the public filed about them.
Orthofix recalls MINIRAIL unilateral external fixation devices with incorrect labeling (M101 labeled as M103, etc.). Affected units have GTIN# 18032568866650. No immediate action needed but verify labeling.
Orthofix recalls Minirail M122 unilateral orthopedic fixators due to incorrect labeling. Check if your device has wrong model numbers like M101 labeled as M103.
Orthofix recalls unilateral orthopedic external fixators with incorrect labeling that could lead to misuse. Affected models include M101, M103, M111, and M122. No remedy specified in official notice.
Orthofix recalls MINIRAIL Standard Lengthener Model M101 due to mislabeling risks incorrect use. Check your device's model number against the recall list.
Orthofix U.S. LLC recalls FORZA PTC Spacer Systems with model numbers 38-1007SP to 38-9014SP due to inconsistent labeling claims. No remedy is specified in the recall notice.
Orthofix U.S. LLC recalls Pillar SA PTC Spacer Systems with inconsistent labeling. Affected models include 39-9012SP to 39-2218SP. No remedy specified in recall notice.
Orthofix U.S. LLC recalls FIREBIRD SI Fusion System screws due to inconsistent labeling. Affected models include 11mm and 12mm screws with specific catalog numbers. No action required as labeling issues do not pose safety risks.
Orthofix recalls CONSTRUX Mini PTC Spacer Systems with inconsistent labeling claims. Affected models include various sizes and lordotic angles. No action needed as labeling issues don't pose safety risks.
Orthofix U.S. LLC recalls CONSTRUX Mini Ti Spacer System (models 37-6005SP to 37-9312SP) due to inconsistent labeling claims. No remedy specified in recall notice.
Orthofix U.S. LLC recalls Forza Ti Spacer Systems with model numbers 38-2006SP to 38-3914SP due to inconsistent labeling claims. No remedy is specified in the recall notice.
Orthofix recalls 25 specific sizes of Virata Preassembled Polyaxial Screws used in spinal fixation systems due to not meeting performance standards. Affected items include 5.5mm and 6.5mm screws with various lengths and lot numbers.
Orthofix recalls specific 37mm PILLAR SA Ti spinal fusion devices due to incorrect label width measurements. This labeling error may cause improper surgical use. Affected devices have UDI-DI: 18257200161010 and lots 001-003.
Orthofix recalls three spinal implant models due to mislabeled anterior height (10mm vs 10.5mm). This could affect spinal fusion surgery accuracy. Contact Orthofix for details.
