Class IIIOngoingZ-0896-2026
Orthofix U.S. LLC recalls Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer Sys…
Orthofix U.S. LLCLewisville, TX, United StatesReported Dec 17, 2025 · 7 months ago
Legal News Analyst ·
Reason for recall
Labeling contains claims that are not consistently present.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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¿ LordoticUDI 37-6005SP400 affected lots37-6005SP1825720015015137-6005SP1825720015015137-6005SP1825720015015137-6006SP18257200150168
+392 more
37-6006SP1825720015016837-6006SP1825720015016837-6007SP1825720015017537-6007SP1825720015017537-6007SP1825720015017537-6008SP1825720015018237-6008SP1825720015018237-6008SP1825720015018237-6009SP1825720015019937-6009SP1825720015019937-6009SP1825720015019937-6010SP1825720015020537-6010SP1825720015020537-6010SP1825720015020537-6011SP1825720015021237-6011SP1825720015021237-6011SP1825720015021237-6012SP1825720015022937-6012SP1825720015022937-6012SP1825720015022937-6105SP1825720014975937-6105SP1825720014975937-6105SP1825720014975937-6106SP1825720014976637-6106SP1825720014976637-6106SP1825720014976637-6107SP1825720014977337-6107SP1825720014977337-6107SP1825720014977337-6108SP1825720014978037-6108SP1825720014978037-6108SP1825720014978037-6109SP1825720014979737-6109SP1825720014979737-6109SP1825720014979737-6110SP1825720014980337-6110SP1825720014980337-6110SP1825720014980337-6111SP1825720014981037-6111SP1825720014981037-6111SP1825720014981037-6112SP1825720014982737-6112SP1825720014982737-6112SP1825720014982737-6206SP1825720015055737-6206SP1825720015055737-6206SP1825720015055737-6207SP1825720015056437-6207SP1825720015056437-6207SP1825720015056437-6208SP1825720015057137-6208SP1825720015057137-6208SP1825720015057137-6209SP1825720015058837-6209SP1825720015058837-6209SP1825720015058837-6210SP1825720015059537-6210SP1825720015059537-6210SP1825720015059537-6211SP1825720015060137-6211SP1825720015060137-6211SP1825720015060137-6212SP1825720015061837-6212SP1825720015061837-6212SP1825720015061837-6306SP1825720015091537-6306SP1825720015091537-6306SP1825720015091537-6307SP1825720015092237-6307SP1825720015092237-6307SP1825720015092237-6308SP1825720015093937-6308SP1825720015093937-6308SP1825720015093937-6309SP1825720015094637-6309SP1825720015094637-6309SP1825720015094637-6310SP1825720015095337-6310SP1825720015095337-6310SP1825720015095337-6311SP1825720015096037-6311SP1825720015096037-6311SP1825720015096037-6312SP1825720015097737-6312SP1825720015097737-6312SP1825720015097737-7005SP1825720015025037-7005SP1825720015025037-7005SP1825720015025037-7006SP1825720015026737-7006SP1825720015026737-7006SP1825720015026737-7007SP1825720015027437-7007SP1825720015027437-7007SP1825720015027437-7008SP1825720015028137-7008SP1825720015028137-7008SP1825720015028137-7009SP1825720015029837-7009SP1825720015029837-7009SP1825720015029837-7010SP1825720015030437-7010SP1825720015030437-7010SP1825720015030437-7011SP1825720015031137-7011SP1825720015031137-7011SP1825720015031137-7012SP1825720015032837-7012SP1825720015032837-7012SP1825720015032837-7105SP1825720014985837-7105SP1825720014985837-7105SP1825720014985837-7106SP1825720014986537-7106SP1825720014986537-7106SP1825720014986537-7107SP1825720014987237-7107SP1825720014987237-7107SP1825720014987237-7108SP1825720014988937-7108SP1825720014988937-7108SP1825720014988937-7109SP1825720014989637-7109SP1825720014989637-7109SP1825720014989637-7110SP1825720014990237-7110SP1825720014990237-7110SP1825720014990237-7111SP1825720014991937-7111SP1825720014991937-7111SP1825720014991937-7112SP1825720014992637-7112SP1825720014992637-7112SP1825720014992637-7206SP1825720015064937-7206SP1825720015064937-7206SP1825720015064937-7207SP1825720015065637-7207SP1825720015065637-7207SP1825720015065637-7208SP1825720015066337-7208SP1825720015066337-7208SP1825720015066337-7209SP1825720015067037-7209SP1825720015067037-7209SP1825720015067037-7210SP1825720015068737-7210SP1825720015068737-7210SP1825720015068737-7211SP1825720015069437-7211SP1825720015069437-7211SP1825720015069437-7212SP1825720015070037-7212SP1825720015070037-7212SP1825720015070037-7306SP1825720015100437-7306SP1825720015100437-7306SP1825720015100437-7307SP1825720015101137-7307SP1825720015101137-7307SP1825720015101137-7308SP1825720015102837-7308SP1825720015102837-7308SP1825720015102837-7309SP1825720015103537-7309SP1825720015103537-7309SP1825720015103537-7310SP1825720015104237-7310SP1825720015104237-7310SP1825720015104237-7311SP1825720015105937-7311SP1825720015105937-7311SP1825720015105937-7312SP1825720015106637-7312SP1825720015106637-7312SP1825720015106637-8005SP1825720015035937-8005SP1825720015035937-8005SP1825720015035937-8006SP1825720015036637-8006SP1825720015036637-8006SP1825720015036637-8007SP1825720015037337-8007SP1825720015037337-8007SP1825720015037337-8008SP1825720015038037-8008SP1825720015038037-8008SP1825720015038037-8009SP1825720015039737-8009SP1825720015039737-8009SP1825720015039737-8011SP1825720015041037-8011SP1825720015041037-8011SP1825720015041037-8012SP1825720015042737-8012SP18257200150427
What the firm is doing
On 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
DistributionShow detailsHide
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.
Class IIIWhat this means
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0896-2026
- FDA 510(k) clearance · K203342The device's official FDA premarket clearance record
- FDA device classification · ODPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3080The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Orthofix U.S. LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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