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
72 of 72 products
| Model / number | Product as published |
|---|---|
12mm | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP |
12mm | W X 12mm L, 6mm H, Parallel; 37-3107SP |
12mm | W X 12mm L, 7mm H, Parallel; 37-3108SP |
12mm | W X 12mm L, 8mm H, Parallel; 37-3109SP |
12mm | W X 12mm L, 9mm H, Parallel; 37-3110SP |
12mm | W X 12mm L, 10mm H, Parallel; 37-3111SP |
12mm | W X 12mm L, 11mm H, Parallel; 37-3112SP |
12mm | W X 12mm L, 12mm H, Parallel; 37-3113SP |
12mm | W X 12mm LW, 13mm H, Parallel; 37-3114SP |
12mm | W X 12mm WL, 14mm H, Parallel; 37-3006SP |
12mm | W X 12mm L, 6mm H, 5¿ Lordotic; 37-3007SP |
12mm | W X 12mm L, 7mm H, 5¿ Lordotic; 37-3008SP |
12mm | W X 12mm L, 8mm H, 5¿ Lordotic; 37-3009SP |
12mm | WL X 12mm L, 9mm H, 5¿ Lordotic; 37-3010SP |
12mm | W X 12mm L, 10mm H, 5¿ Lordotic; 37-3011SP |
12mm | W X 12mm L, 11mm H, 5¿ Lordotic; 37-3012SP |
12mm | W X 12mm L, 12mm H, 5¿ Lordotic; 37-3013SP |
12mm | W X 12mm L, 13mm H, 5¿ Lordotic; 37-3014SP |
12mm | W X 12mm L, 14mm H, 5¿ Lordotic; 37-3207SP |
12mm | W X 12mm L, 7mm H, 10¿ Lordotic; 37-3208SP |
- Lot codes and dates
- Lot CodeAll
- Lots/ UDIPart Number GTIN
70 of 70 codes
37-3106SP1825720003059037-3107SP1825720003061337-3108SP1825720003063737-3109SP1825720003065137-3110SP1825720003067537-3111SP1825720003069937-3112SP1825720003071237-3113SP1825720003073637-3114SP1825720003075037-3006SP1825720003041537-3007SP1825720003043937-3008SP1825720003045337-3009SP1825720003047737-3010SP1825720003049137-3011SP1825720003051437-3012SP1825720003053837-3013SP1825720003055237-3014SP1825720003057637-3207SP1825720014635237-3208SP1825720014636937-3209SP1825720014637637-3210SP1825720014638337-3211SP1825720014639037-3212SP1825720014640637-4106SP1825720003095837-4107SP1825720003097237-4108SP1825720003099637-4109SP1825720003101637-4110SP1825720003103037-4111SP18257200031054
74 of 74 codes
37-4008SP1825720003081137-4009SP1825720003083537-4010SP1825720003085937-4011SP1825720003087337-4012SP1825720003089737-4013SP1825720003091037-4014SP1825720003093437-4207SP1825720014642037-4208SP1825720014643737-4209SP1825720014644437-4210SP1825720014645137-4211SP1825720014646837-4212SP1825720014647537-5106SP1825720003131337-5107SP1825720003133737-5108SP1825720003135137-5109SP1825720003137537-5110SP1825720003139937-5111SP1825720003141237-5112SP1825720003143637-5113SP1825720003145037-5114SP1825720003147437-5006SP1825720003113937-5007SP1825720003115337-5008SP1825720003117737-5009SP1825720003119137-5010SP1825720003121437-5011SP1825720003123837-5012SP1825720003125237-5013SP18257200031276
- Amount recalled
- 61977
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.
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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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