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Orthofix U.S. LLC recalls Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33
Recalled December 17, 2025 · FDA recall Z-0893-2026 · Orthofix U.S
Hazard
Labeling contains claims that are not consistently present. · FDA Class III
Units
13317
Sold at
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.
Description
Labeling contains claims that are not consistently present.
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;
Manufacturer(s)
Orthofix U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →