Class 3 Device Recall CONSTRUX" Mini PTC Spacer System

• Date Initiated by Firm: November 03, 2025
• Date Posted: December 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0891-2026
• Recall Event ID: 97862
• 510(K)Number: K172437
• Product Classification: Intervertebral fusion device with bone graft, cervical - Product Code ODP
• Product: Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5 Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5 Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5 Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5 Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5 Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5 Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5 Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5 Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5 Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10 Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10 Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10 Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10 Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10 Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10 Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5 Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5 Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5 Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5 Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5 Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5 Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5 Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5 Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5 Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10 Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10 Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10 Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10 Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10 Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10 Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5 Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5 Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5 Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5 Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5 Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5 Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5 Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5 Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5 Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10 Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10 Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10 Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10 Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10 Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10 Lordotic
• Code Information: Lot Code: All Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550
• Recalling Firm/ Manufacturer: Orthofix U.S. LLC; 3451 Plano Pkwy; Lewisville TX 75056-9453
• For Additional Information Contact: Orthofix Field Actions; 214-937-2000
• Manufacturer Reason for Recall: Labeling contains claims that are not consistently present.
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 61977
• Distribution: 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.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = ODP