FDA-Device2025-09-17Class II
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Orthofix U.S. LLC
Hazard
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.
Sold states
US Nationwide distribution in the states of CO, CA.
Affected count
3
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2555-2025Don't want to check this manually?
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