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

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/d7946fb6-0cbf-449c-85bd-96b9af137f87/
Source feed: China

> China NMPA product recall for Injectable beta-tricalcium phosphate artificial bone (trade name: chronOSTM) by Synthes GmbH published December 09, 2015. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., working with manufacturer Synthes GmbH, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling injectable beta-tricalcium phosphate artificial bone (trade name: chronOSTM).
- Company Name: Synthes GmbH
- Publication Date: 2015-12-09
- Product Name: Injectable beta-tricalcium phosphate artificial bone (trade name: chronOSTM)
- Recall Level: Level II
- Recall Reason: The manufacturer issued a field safety notice because incorrect English instructions were found in the affected products. The approved English instructions contain more precautions and information on possible side effects, adverse reactions, and potential complications, designed to inform the attending physician and inform pre- and post-operative medical plans. Key health risks mentioned in the approved English instructions are local adverse tissue reactions, transient local adverse tissue reactions, and pain (borderline). The omission of this information may lead to user complaints, but the product is intact and does not increase the risk to the user or patient. The Chinese instructions are the approved version and are currently being updated to include precautions and information on possible side effects, adverse reactions, and potential complications consistent with the approved English instructions. No related complaints or adverse events have been reported in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7/