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U.S. Department of Health and Human Services

Class 3 Device Recall CONSTRUX" Mini Ti Spacer System

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 Class 3 Device Recall CONSTRUX" Mini Ti Spacer Systemsee related information
Date Initiated by FirmNovember 03, 2025
Date PostedDecember 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0896-2026
Recall Event ID 97862
510(K)NumberK203342 
Product Classification Intervertebral fusion device with bone graft, cervical - Product Code ODP
ProductBrand 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
Code Information 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
Recalling Firm/
Manufacturer		 Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactOrthofix Field Actions
214-937-2000
Manufacturer Reason
for Recall		Labeling contains claims that are not consistently present.
FDA Determined
Cause 2		Device Design
ActionOn November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions: 1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website. 2. No product return is being requested. You may continue to use the product. 3. Distribute this Notice to all relevant personnel within your organization. 4. Forward this Notice to other organization or facilities where affected products may have been transferred. 5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com
Quantity in Commerce40956
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ODP
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