Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error on a Class II medical device with no reported injuries or illnesses. The actual implant dimensions are correct as indicated by the laser marking; the discrepancy exists only on the external label.
Plain-English summary
Orthofix U.S. LLC is recalling the Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device due to a labeling error. The product label states an anterior height of 10mm, but the laser marking on the implant and the corresponding surgical trial show the correct anterior height of 10.5mm. This discrepancy between the label and actual device dimensions could lead to confusion during surgical planning and placement.
The recall affects three reference models: REF 82-3300SP (33mm W x 24mm D x 10mm H, 7 degrees), REF 82-3700SP (37mm W x 28mm D x 10mm H, 7 degrees), and REF 82-4000SP (40mm W x 32mm D x 10mm H, 7 degrees). A total of 20 units were distributed nationwide in California, Colorado, and Missouri.
Healthcare providers who received these devices should verify the actual implant dimensions by checking the laser marking on the device itself (10.5mm) rather than relying on the external label (10mm) before surgical use. Contact Orthofix U.S. LLC for questions or to report any issues.
The recalled product
- Product
- Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- (1) REF 82-3300SP - Lot Number 001
- UDI 18257200160426
- (2) REF 82-3700SP - Lot Number 001
- UDI 18257200160884
- and (3) REF 82-4000SP - Lot Number 001
- UDI 18257200161270.
Distribution
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