Reported Apr 2, 2025 · Ongoing
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:…
Orthofix U.S. LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy
3 of 3 products
| Model / number | Product as published |
|---|---|
82-3300SP | (1) , 33mm W x 24mm D x 10mm H, 7 degrees |
82-3700SP | (2) , 37mm W x 28mm D x 10mm H, 7 degrees |
82-4000SP | and (3) , 40mm W x 32mm D x 10mm H, 7 degrees. |
- Lot codes and dates
(1) REF 82-3300SP - Lot Number 001UDI 18257200160426(2) REF 82-3700SP - Lot Number 001UDI 18257200160884and (3) REF 82-4000SP - Lot Number 001UDI 18257200161270
- Amount recalled
- 20
Where it was sold
Why it was recalled
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
This product could cause temporary or reversible health problems — stop using it.
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