Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.
Labeling contains claims that are not consistently present.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
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The Pillar PTC Spacer System is a medical device used in orthopedic procedures to support bone healing and alignment. Healthcare providers typically use these implants during surgeries to improve patient outcomes.
The recall is due to inconsistent labeling claims that could mislead healthcare providers and patients about the device's intended use or effectiveness. This inconsistency can lead to potential misuse or complications during treatment.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face potential health risks due to misleading labeling. Immediate action is necessary to avoid adverse health effects.
You can typically find the model number and UDI on the device packaging or directly on the device itself.
Expect a timeline of 4-6 weeks for processing refunds or replacements once initiated with the manufacturer.
Keep all correspondence related to the recall and any documents proving purchase or communication with the manufacturer.
The recalled models include 39-9012SP, 39-9014SP, 39-9016SP, 39-9018SP, 39-9212SP, 39-9214SP, 39-9216SP, 39-9218SP, 39-2012SP, 39-2014SP, 39-2016SP, 39-2018SP, 39-2212SP, 39-2214SP, 39-2216SP, 39-2218SP. These devices were distributed worldwide, including states such as CA, TX, and NY. No specific price was provided.
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