HIGH

Orthofix Recalls CONSTRUX Mini Ti Spacer System Over Labeling Issues

Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
November 3, 2025
Hazard Level
HIGH
Brand
Orthofix U.S.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Labeling contains claims that are not consistently present.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recall affects the CONSTRUX Mini Ti Spacer System, model numbers 37-6005SP through 37-9312SP. The dimensions vary by model, generally measuring 12mm W x 12mm L with various heights. These devices were distributed worldwide, including across all U.S. states.

The Hazard

The labeling of the CONSTRUX Mini Ti Spacer System contains claims that are not consistently present. This inconsistency can lead to improper use and potential harm to patients.

Reported Incidents

There are no reported injuries or incidents associated with this recall. The recall was issued as a precaution due to labeling concerns.

What to Do

Stop using the device immediately. Healthcare providers should contact Orthofix U.S. LLC or their healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.

Contact Information

For more information, contact Orthofix U.S. LLC via email. For further assistance, visit the recall page at the FDA website.

Key Facts

  • Model numbers affected: 37-6005SP to 37-9312SP
  • Total quantity recalled: 40,956
  • Recall issued on November 3, 2025
  • Labeling inconsistencies noted as hazard
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSpinal Implant
Sold At
Multiple Retailers

Product Details

Model Numbers
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 18257200150700 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7312SP 18257200151066 37-7312SP 18257200151066 37-7312SP 18257200151066 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8312SP 18257200151158 37-8312SP 18257200151158 37-8312SP 18257200151158 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9012SP 18257200150526 37-9012SP 18257200150526 37-9105SP 18257200150052 37-9105SP 18257200150052 37-9106SP 18257200150069 37-9106SP 18257200150069 37-9107SP 18257200150076 37-9107SP 18257200150076 37-9108SP 18257200150083 37-9108SP 18257200150083 37-9109SP 18257200150090 37-9109SP 18257200150090 37-9110SP 18257200150106 37-9110SP 18257200150106 37-9111SP 18257200150113 37-9111SP 18257200150113 37-9112SP 18257200150120 37-9112SP 18257200150120 37-9206SP 18257200150823 37-9206SP 18257200150823 37-9207SP 18257200150830 37-9207SP 18257200150830 37-9208SP 18257200150847 37-9208SP 18257200150847 37-9209SP 18257200150854 37-9209SP 18257200150854 37-9210SP 18257200150861 37-9210SP 18257200150861 37-9211SP 18257200150878 37-9211SP 18257200150878 37-9212SP 18257200150885 37-9212SP 18257200150885 37-9306SP 18257200151189 37-9306SP 18257200151189 37-9307SP 18257200151196 37-9307SP 18257200151196 37-9308SP 18257200151202 37-9308SP 18257200151202 37-9309SP 18257200151219 37-9309SP 18257200151219 37-9310SP 18257200151226 37-9310SP 18257200151226 37-9311SP 18257200151233 37-9311SP 18257200151233 37-9312SP 18257200151240 37-9312SP 18257200151240
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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