HIGH

Orthofix Recalls Intervertebral Body Fusion Device Over Labeling Error

Orthofix U.S. recalled three intervertebral body fusion devices on June 24, 2025. A labeling error states the width as 33 mm instead of the correct 37 mm. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
June 24, 2025
Hazard Level
HIGH
Brand
Orthofix U.S.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 front labels is correct.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the PILLAR SA Ti, sterile, with dimensions of 37mm (W) x 28mm (D) x 18mm (H). It was distributed nationwide in the U.S., particularly in Colorado and California.

The Hazard

The device has a labeling discrepancy that could lead to improper use. The outer label states an incorrect width of 33 mm, potentially causing complications during procedures.

Reported Incidents

No injuries or incidents have been reported due to this labeling issue. The recall affects a total of three devices.

What to Do

Patients and healthcare providers should stop using the affected devices immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions.

Contact Information

For more information, call Orthofix U.S. LLC or visit their website. Additional details are available at the FDA recall notice.

Key Facts

  • Recall date: June 24, 2025
  • Active recall status
  • Class II medical device
  • Incorrect labeling on packaging

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI: 18257200161010
Lots: 001
002
and 003
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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