Pillar SA Ti recall: Labeling Error
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Why was Pillar SA Ti recalled?
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.
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?
UDI-DI: 18257200161010, Lots: 001, 002, and 003
- Product
- PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of CO, CA.
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)