FDA Medical devices recall ·
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees recall
- Recall number
- Z-2555-2025
- Date
- (initiated June 24, 2025)
- Company / brand
- Orthofix U.S. LLC
3451 Plano Pkwy, Lewisville, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 18257200161010, Lots: 001, 002, and 003
Distribution
US Nationwide distribution in the states of CO, CA.
States: California Colorado
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2555-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.