Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 17, 2025
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
🔢 3
Sold At: Orthofix U.S. LLC(US Nationwide distribution in the states of CO, CA.)
Recall #: FDA-DEVICE-Z-2555-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI-DI: 18257200161010, Lots: 001, 002, and 003
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Summary
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 to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Orthofix U.S. LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.