| | Class 3 Device Recall FORZA" PTC Spacer System |  |
| Date Initiated by Firm | November 03, 2025 |
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| Date Posted | December 11, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0892-2026 |
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| Recall Event ID |
97862 |
| 510(K)Number | K172437 |
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| Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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| Product | Brand Name: FORZA" PTC Spacer System
Product Name: FORZA" PTC Spacer System
Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H
38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H;
38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H;
38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H;
38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H;
38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H;
38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H;
38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H;
38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H;
38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H;
38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H;
38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H;
38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H;
38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H;
38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H;
38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H;
38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H;
38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H;
38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H;
38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H;
38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H;
38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H;
38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H;
38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H;
38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H;
38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H;
38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H;
38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H;
38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H;
38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H;
38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H;
38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H;
38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H;
38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H;
38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H;
38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H;
38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H;
38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H;
38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H;
38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H;
38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H;
38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H;
38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H;
38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H;
38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H;
38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H;
38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H;
38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H;
38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H;
38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H;
38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H;
38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H;
38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H;
38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H;
38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H;
38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H;
38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H;
38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H;
38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H;
38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H;
38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H;
38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H;
38-6014SP FORZA PTC Spacer, |
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| Code Information |
Lot Code: All Lot codes/ UDI: 38-1007SP 18257200091577
38-1008SP 18257200091584
38-1009SP 18257200091591
38-1010SP 18257200111404
38-1011SP 18257200091614
38-1012SP 18257200091621
38-1013SP 18257200091638
38-1014SP 18257200091645
38-1707SP 18257200092185
38-1708SP 18257200092192
38-1709SP 18257200092208
38-1710SP 18257200092215
38-1711SP 18257200092222
38-1712SP 18257200092239
38-1713SP 18257200092246
38-1714SP 18257200092253
38-1807SP 18257200092024
38-1808SP 18257200092031
38-1809SP 18257200092048
38-1810SP 18257200092055
38-1811SP 18257200092062
38-1812SP 18257200092079
38-1813SP 18257200111305
38-1814SP 18257200092093
38-3007SP 18257200091881
38-3008SP 18257200091898
38-3009SP 18257200091904
38-3010SP 18257200091911
38-3011SP 18257200091928
38-3012SP 18257200091935
38-3013SP 18257200091942
38-3014SP 18257200091959
38-4007SP 18257200091720
38-4008SP 18257200091737
38-4009SP 18257200091744
38-4010SP 18257200091751
38-4011SP 18257200111411
38-4012SP 18257200091775
Part Number GTIN
38-4013SP 18257200091782
38-4014SP 18257200091799
38-4207SP 18257200092109
38-4208SP 18257200092116
38-4209SP 18257200092123
38-4210SP 18257200092130
38-4211SP 18257200092147
38-4212SP 18257200092154
38-4213SP 18257200092161
38-4214SP 18257200092178
38-4508SP 18257200092260
38-4509SP 18257200092277
38-4510SP 18257200092284
38-4511SP 18257200092291
38-4512SP 18257200092307
38-4513SP 18257200092314
38-4514SP 18257200092321
38-6007SP 18257200091805
38-6008SP 18257200091812
38-6009SP 18257200091829
38-6010SP 18257200091836
38-6011SP 18257200091843
38-6012SP 18257200091850
38-6013SP 18257200091867
38-6014SP 18257200091874
38-7008SP 18257200091652
38-7009SP 18257200091669
38-7010SP 18257200091676
38-7011SP 18257200091683
38-7012SP 18257200091690
38-7013SP 18257200091706
38-7014SP 18257200091713
38-9009SP 18257200091966
38-9010SP 18257200091973
38-9011SP 18257200091980
38-9012SP 18257200091997
38-9013SP 18257200092000
38-9014SP 18257200092017
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Recalling Firm/
Manufacturer |
Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
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| For Additional Information Contact | Orthofix Field Actions
214-937-2000 |
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Manufacturer Reason
for Recall | Labeling contains claims that are not consistently present. |
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FDA Determined
Cause 2 | Device Design |
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| 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
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| Quantity in Commerce | 34582 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = MAX
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