Orthofix Pillar SA Ti Spacer System Intervertebral Body recall: Labeling Error
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm…
Why was Orthofix Pillar SA Ti Spacer System Intervertebral Body 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(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.
- 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…
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 20
- Distribution
- US Nationwide distribution in the states of California, Colorado, and Missouri.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)