Class III U.S. Food and Drug Administration

Orthofix U.S. LLC Brand Name: Construx" Mini Ti Spacer System Product Name: Construx" recall: Labeling contains claims that are not consistently present

Recall published 10 months ago

Labeling contains claims that are not consistently present.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Labeling contains claims that are not consistently present.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0896-2026
Published
December 17, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Orthofix U.S. LLC
Product type
Medical devices
Units affected
40956
Distribution
Nationwide
Made in
United States
Lot / code info
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 18257200150946 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6312SP 18257200150977 37-6312SP 18257200150977 37-6312SP 18257200150977 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7212SP 182572001…
UPC codes
18257200150151, 18257200150168, 18257200150175, 18257200150182, 18257200150199, 18257200150205, 18257200150212, 18257200150229, 18257200149759, 18257200149766, 18257200149773, 18257200149780, 18257200149797, 18257200149803, 18257200149810, 18257200149827, 18257200150557, 18257200150564, 18257200150571, 18257200150588

Products covered by this recall

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

Check your product

The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 18257200150151
  • 18257200150168
  • 18257200150175
  • 18257200150182
  • 18257200150199
  • 18257200150205
  • 18257200150212
  • 18257200150229
  • 18257200149759
  • 18257200149766
  • 18257200149773
  • 18257200149780
  • 18257200149797
  • 18257200149803
  • 18257200149810
  • 18257200149827
  • 18257200150557
  • 18257200150564
  • 18257200150571
  • 18257200150588

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 5mm H

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Orthofix U.S. LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Orthofix U.S. LLC — 3451 Plano Pkwy, Lewisville, TX, 75056-9453

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Orthofix U.S. LLC medical devices recalled?

Labeling contains claims that are not consistently present. Labeling contains claims that are not consistently present.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 18257200150151, 18257200150168, 18257200150175; lot code UDI; model number 5mm H. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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