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PILLAR SA PTC recallZ-0893-2026 · 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-0893-2026
Status
Open, Classified
Initiated by the company
Nov 3, 2025
Posted by the FDA
Dec 11, 2025
Recalling firm
Orthofix U.S. LLC
Quantity
13317
Product code
OVD
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: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT;

Code information (models, lots, serial numbers)

Lot Code: All Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

114 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

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