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Orthofix U.S. LLC
2 federal recalls on file, showing the 1 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Orthofix U.S. LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-17FDA-DeviceClass IIPILLAR 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 front labels is correct.
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