Z-0893-2026Class III

Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number...

Name: Z-0893-2026 Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number...
Creator: Orthofix U.S. LLC
Published: 2025-11-03
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2025-11-03 / Open, Classified / root cause: design

FDA source

Orthofix U.S. LLC began a recall of 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... on 2025-11-03. FDA classified it as Class III and gives the reason as "Labeling contains claims that are not consistently present". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0893-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-11-03
Posted: 2025-12-11
Recalling firm: Orthofix SRL
Product: 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;
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Labeling contains claims that are not consistently present.
Root cause tag: design
FDA root 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 [email protected]
Quantity in commerce: 13317
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0893-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0891-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0892-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0893-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0894-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0895-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11
Z-0896-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code OVD

K172437Class IICONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc. / cleared 2017-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)