Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33
Summary
The FDA issued a Class III for Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer Sy by Orthofix U.S. LLC. Reason: Labeling contains claims that are not consistently present..
Details
Source
Device Recall
External ID
Z-0893-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
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;
Lot/Code Info: 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
Quantity Affected: 13317
Reason for Recall
Labeling contains claims that are not consistently present.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-03
Company
Lewisville, TX
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orthofix U.S. LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orthofix U.S. LLC have FDA actions?
Orthofix U.S. LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0893-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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