Recall record at a glance
| Official record | Z-0896-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Ongoing |
| Recalling firm | Orthofix U.S. LLC |
| Report date | Dec 17, 2025 |
| Recall initiation date | Nov 3, 2025 |
| Quantity | 40956 |
| Location | Lewisville, TX, United States |
Official product description
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic
Why the product was recalled
Labeling contains claims that are not consistently present.
Distribution information
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, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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