Reported Dec 17, 2025 · Ongoing
Brand Name
Orthofix U.S. LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
Brand Name
66 of 66 products
| Model / number | Product as published |
|---|---|
12mm | 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 |
- Lot codes and dates
- Lot CodeAll
- Lot Codes/ UDI
668 of 668 codes
37-6005SP1825720015015137-6005SP1825720015015137-6005SP1825720015015137-6006SP1825720015016837-6006SP1825720015016837-6006SP1825720015016837-6007SP1825720015017537-6007SP1825720015017537-6007SP1825720015017537-6008SP1825720015018237-6008SP1825720015018237-6008SP1825720015018237-6009SP1825720015019937-6009SP1825720015019937-6009SP1825720015019937-6010SP1825720015020537-6010SP1825720015020537-6010SP1825720015020537-6011SP1825720015021237-6011SP1825720015021237-6011SP1825720015021237-6012SP1825720015022937-6012SP1825720015022937-6012SP1825720015022937-6105SP1825720014975937-6105SP1825720014975937-6105SP1825720014975937-6106SP1825720014976637-6106SP1825720014976637-6106SP18257200149766
- Amount recalled
- 40956
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Labeling contains claims that are not consistently present.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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