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FDA-Device2025-12-17Class IIIMISBRANDING

Orthofix Pillar SA PTC Spacer System recalled for inconsistent labeling claims

Orthofix
FALSE CLAIMSNationwide distribution

Check Orthofix Pillar SA spacer labeling

Orthofix U.S. LLC is recalling multiple models of the Pillar SA PTC Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue affecting the information provided with the device.

  • If you have received one of the affected Pillar SA PTC Spacer System models, verify the labeling against the product documentation provided by your supplier.
  • Contact Orthofix U.S. LLC or your distributor for corrected labeling or further instructions.
  • Do not rely on inconsistent labeling claims when using the device.
Hazard

Labeling contains claims that are not consistently present.

Sold states
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.
Affected count
13317
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0893-2026

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