Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-600

Recalled December 17, 2025 · FDA recall Z-0896-2026 · Orthofix U.S

Hazard

Labeling contains claims that are not consistently present. · FDA Class III

Units

40956

Sold at

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.

Description

Labeling contains claims that are not consistently present.

Product

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

Manufacturer(s)

Orthofix U.S. LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →