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 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.
The recall stems from labeling claims that are not consistently present, potentially leading to misuse of the devices. This inconsistency raises significant safety concerns for patients relying on correct information.
No specific incidents or injuries related to the recalled products have been reported. The company has classified this recall as Class III, indicating it poses a low risk.
Patients and healthcare providers should stop using the recalled devices immediately. Follow the recall instructions provided by Orthofix, and contact either the manufacturer or your healthcare provider for further guidance.
For more information, contact Orthofix U.S. LLC via email or visit their website. Additional recall details are available at the FDA's enforcement report page.
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