Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005S
FDA device recall Z-0896-2026 · posted 2025-12-11 · Open, Classified
Recall details
- Recalling firm
- Orthofix U.S. LLC
- Reason for recall
- Labeling contains claims that are not consistently present.
- Action taken
- On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions: 1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website. 2. No product return is being requested. You may continue to use the product. 3. Distribute this Notice to all relevant personnel within your organization. 4. Forward this Notice to other organization or facilities where affected products may have been transferred. 5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- ODP
- Quantity affected
- 40956
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR
- Date initiated
- 2025-11-03
- Date posted
- 2025-12-11
- Location
- Lewisville, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONSTRUX Mini Ti Spacer System (K203342) | Orthofix, Inc. | 2021-03-18 |