Orthofix PILLAR SA Spinal Implant Recalled for Labeling Width Error
Orthofix recalled the PILLAR SA Ti spinal implant due to labeling errors stating 33mm width instead of the actual 37mm. The discrepancy affects three lots distributed in Colorado and California.
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: FDA Class II recall for labeling discrepancy with no reported illnesses, injuries, or adverse events. The incorrect width information appears only on secondary labels (side flap and info box), while the front label provides correct specification. This qualifies as a minor labeling error.
Plain-English summary
Orthofix U.S. LLC is recalling the PILLAR SA Ti intervertebral body fusion implant (37mm width x 28mm depth x 18mm height, 20-degree angle, REF: 82-3713SP). The device is a sterile surgical implant used in intervertebral fusion procedures.
The recall is due to a labeling discrepancy. The outer label side flap and inner label information box incorrectly state the implant width as 33mm, while the actual product width is 37mm. The front labels correctly identify the 37mm width.
The recall affects three lots (001, 002, and 003) distributed in Colorado and California. The total quantity recalled is three units.
Healthcare providers and facilities that received this product should verify the actual product width before use and cross-reference it with surgical documentation. Anyone who has experienced adverse events related to this product should report them immediately to Orthofix U.S. LLC and the FDA.
The recalled product
- Product
- PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
- Manufacturer
- Orthofix U.S. LLC
- Hazard
- labeling-error
- width-mismatch
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 (4)
- UDI-DI: 18257200161010
- Lots: 001
- 002
- and 003
Distribution
Distributed nationwide across the United States.
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