Brand Name: CONSTRUX” Mini Ti Spacer System Product Name: CONSTRUX” Mini Ti Spacer System
Medical device recall Z-0896-2026. Published in FDA’s Enforcement Report on Dec 17, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 17, 2025. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 46 states named
- 40956 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Labeling contains claims that are not consistently present.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
40956, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP…
Every code shown here, 1,990 characters
Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6309SP…
FDA’s list runs to 8,379 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
46 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2025.
- FDA classified it on Dec 11, 2025.
- FDA’s Enforcement Report published it on Dec 17, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Orthofix U.S. LLC, of Lewisville, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,379 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.