Intervertebral fusion implants recalled over incorrect width printed on side labels
PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.
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: Rubric level 2 covers minor labeling errors; the discrepancy is confined to the side flap labels and the front labels state the correct width.
Plain-English summary
The PILLAR SA Ti, sterile, 37 mm wide by 28 mm deep by 18 mm high at 20 degrees, REF 82-3713SP, UDI-DI 18257200161010, is being recalled for lots 001, 002 and 003. The recall covers 3 units distributed in Colorado and California.
The 37 mm implant width intervertebral body fusion device has a labeling discrepancy, with an incorrect width of 33 mm stated on the outer label side flap and the inner label side flap information box. The notice states the 37 mm width shown on the front labels is correct. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
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
- spinal-implant
- class-ii
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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