# China NMPA Product Recall - Artificial hip joint prosthesis components (trade name: Pinnacle)

Source: https://www.globalkeysolutions.net/records/china_product_recall/depuy-orthopaedics-inc/d9e5cf57-846b-4e54-9c3e-1f237ba8b4fa/
Source feed: China

> China NMPA product recall for Artificial hip joint prosthesis components (trade name: Pinnacle) by DePuy Orthopaedics, Inc. published March 17, 2017. Recall level: . The National Medical Products Administration (NMPA) of China published a report on March 17, 2017, d

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: DePuy Orthopaedics, Inc. is recalling artificial hip joint prosthesis components (trade name: Pinnacle).
- Company Name: DePuy Orthopaedics, Inc.
- Publication Date: 2017-03-17
- Product Name: Artificial hip joint prosthesis components (trade name: Pinnacle)
- Recall Reason: A customer complained that they received a box (product model: 121712058, product number: 121714050, product batch number: H03632), but upon opening the box, they found that the actual product was (product model: 121714050, product batch number: H03632).
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: DePuy Orthopaedics, Inc.
- Summary: The National Medical Products Administration (NMPA) of China published a report on March 17, 2017, detailing a voluntary recall initiated by DePuy Orthopaedics, Inc., a Johnson & Johnson company. The recall, reported on February 21, 2017, concerned artificial hip joint prosthesis components sold under the trade name Pinnacle. The core issue arose from a customer complaint indicating a product mix-up: a box labeled for model 121712058 was found to contain a different product, model 121714050, batch number H03632, upon opening. The specific recalled product is model 1217-12-058, batch number H03642, which points to a critical packaging or labeling error. Operating under the NMPA's regulatory framework, referencing NMPA Index No. JGXX-2017-10234 and CFDA (Imported) 2014 No. 3460154 (Revised), DePuy Orthopaedics initiated the recall. Crucially, the company confirmed that zero units of the affected product were imported into or sold within China. Consequently, no direct corrective actions were required for products in the Chinese market. However, the NMPA requested local food and drug administrations to enhance their supervision and management of similar medical devices. The recall primarily targeted international markets, including France, the UK, Australia, and Belgium, with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. serving as the responsible contact in China.

Company: https://www.globalkeysolutions.net/companies/depuy-orthopaedics-inc/abe8ff95-754c-4e38-898b-9df32f104a7a/