Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
- Recall date
- June 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2555-2025
- FDA classification
- Class II
- Brand / firm
- Orthofix U.S. LLC
- Sold / distributed
- US Nationwide distribution in the states of CO, CA.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
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