FDA Medical devices recall ·
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm recall
- Recall number
- Z-0125-2025
- Date
- (initiated August 21, 2024)
- Company / brand
- XTANT Medical Holdings, Inc
664 Cruiser Ln, Belgrade, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 330
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Why was it recalled?
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
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: 00810076563190, Lot: DNI
Distribution
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
States: California Florida Illinois Massachusetts Michigan Missouri Ohio Pennsylvania Texas Virginia Wisconsin
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-0125-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.