China NMPA Product Recall - Artificial hip joint prosthesis components (trade name: Pinnacle)
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DePuy Orthopaedics, Inc., a manufacturer, initiated a voluntary recall of specific artificial hip joint prosthesis components, marketed under the trade name Pinnacle, with distribution in China handled by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall was prompted by a customer complaint detailing a product mix-up: a box labeled with model 121712058 (batch H03642) contained an incorrect product, model 121711050 (batch H03632), upon opening. This indicated a significant packaging error. The National Medical Products Administration (NMPA) publicized this recall notice. Crucially, the manufacturer confirmed that the specific recalled product lot was not sold or distributed within the Chinese market. Therefore, Johnson & Johnson Medical (China) Ltd. stated that no corrective actions are necessary for China, as there were no affected products to retrieve from the local supply chain. The incident underscores the importance of precise labeling and packaging integrity in the medical device industry, even when products do not reach certain markets.
- Company
- DePuy Orthopaedics, Inc.
ID · a22b6119-df56-489a-b092-b6a529a3d921