Recall of all Precice® System devices due to gaps in biological assessments

A Dear Healthcare Professional Letter has been issued by ConMed Singapore Pte Ltd to inform healthcare professionals of the recall of all Precice^® System devices due to gaps in the biological assessments for these devices. The affected devices are not indicated for use in individuals below 18 years old and do not have the full complement of biological assessments for all potential patients. Additional toxicological risk assessments that are currently undertaken to close these gaps include carcinogenicity, chronic toxicity, developmental toxicity and reproductive toxicity. There had been several reports of adverse events related to the Precice^® Stryde system; the events included pain and bony abnormalities at the interface between the telescoping nail segments. While the root cause has yet to be confirmed, preliminary explant analyses suggest the issues are not of a biological safety origin. No unexpected incidents related to biological safety had been identified post-market with other Precice^® System devices. Healthcare professionals are advised not to implant Precice^® System devices until further notice. Prophylactic removal of functioning devices is not recommended. For patients who are currently between staged surgical interventions or along a continuum of treatment or care with the use of affected devices, healthcare professionals are advised to consider alternative arrangements for treatment during this time. For patients previously implanted with the affected devices and were below 18 years old, are pregnant or become pregnant, consultation may be warranted at the discretion of the healthcare provider. Please refer to the letter for details. Published: 18 Feb 2021

Dear Healthcare Professional Letters