China NMPA Product Recall - Tornier Perform Reversed Shoulder System
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Tornier, Inc. is voluntarily recalling its Tornier PerFORM Reversed Shoulder System, a Class III medical device, as reported by Stryker to the National Medical Products Administration (NMPA) on December 19, 2025. The core issue driving this recall stems from discrepancies identified between the English label information and the actual product contained within the packaging. This inconsistency could lead to potential user confusion or incorrect application of the device. The affected product, registered under National Medical Device Registration Certificate No. 20253130172, requires immediate corrective action by the manufacturer. Detailed information regarding specific models, specifications, and batch numbers impacted by this voluntary recall is available in the associated "Medical Device Recall Event Report Form." The NMPA oversees this regulatory action, ensuring compliance with medical device standards and safeguarding public health. Tornier, Inc. is responsible for implementing the necessary steps to address the labeling discrepancies and prevent further distribution of non-conforming products.
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- Tornier, Inc.
ID · 47b50656-f8c7-469b-b1f0-a76d85d3ea07