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FORZA PTC recallZ-0892-2026 · Orthofix U.S. LLC · initiated Nov 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Orthofix U.S. LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Labeling contains claims that are not consistently present.

FDA root cause category: Device Design

What the company 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 [email protected]

Recall details

Recall number
Z-0892-2026
Status
Open, Classified
Initiated by the company
Nov 3, 2025
Posted by the FDA
Dec 11, 2025
Recalling firm
Orthofix U.S. LLC
Quantity
34582
Product code
MAX
FDA submissions
K172437
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.

Product description

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,

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

76 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

54 devices cleared under K172437 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97862).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page