China NMPA Product Recall - Injectable beta-tricalcium phosphate artificial bone (trade name: chronOSTM)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., working with manufacturer Synthes GmbH, initiated a Class II voluntary recall of its Injectable Tricalcium Beta-Phosphate Artificial Bone, marketed as chronOSTM. This recall, reported on November 3, 2015, and published by the National Medical Products Administration (NMPA) on December 9, 2015 (Index No. JGXX-2015-10249), addresses a critical discrepancy in product labeling.

The main issue involved incorrect English instructions in affected product batches. The approved English instructions included essential details on precautions, potential side effects, adverse reactions, and complications, information vital for medical professionals and patient management. Although the product's integrity was maintained and no direct increase in patient risk was identified, the absence of this comprehensive safety information could lead to user concerns. The existing Chinese instruction manual, while approved, is also undergoing updates to align with the complete English version. No related complaints or adverse events have been reported in China.

Required actions include updating the Chinese instruction manuals for chronOSTM to integrate all necessary safety information. Additionally, the company is responsible for notifying all affected distributors and hospitals to ensure they are aware of the updated product details and implement the changes.