# China NMPA Product Recall - Tibial articular surface pad

Source: https://www.globalkeysolutions.net/records/china_product_recall/united-orthopedic-devices-co-ltd/7b0ae7b5-456c-4957-89da-3aaf7953e3df/
Source feed: China

> China NMPA product recall for Tibial articular surface pad by United Orthopedic Devices Co., Ltd. published November 21, 2017. Recall level: Level 3. United Orthopedic Instruments Co., Ltd. has initiated a voluntary Level III recall of specific medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Announcement Regarding the Voluntary Recall of Relevant Products by United Orthopedic Instruments Co., Ltd.
- Company Name: United Orthopedic Devices Co., Ltd.
- Publication Date: 2017-11-21
- Product Name: Tibial articular surface pad
- Recall Level: Level 3
- Recall Reason: The product inside the packaging does not match its label.
- Discovering Company: United Medical Instruments Co., Ltd.
- Manufacturing Company: United Orthopedic Devices Co., Ltd.
- Summary: United Orthopedic Instruments Co., Ltd. has initiated a voluntary Level III recall of specific medical devices, including the Tibial Stable Type (CFDA Medical Device Permit No. 20133460114) and Tibial Articular Surface Liner, Stable Reinforced Type (CFDA Registration Certificate No. 20143460183). This recall, announced by the National Medical Products Administration (NMPA) on November 21, 2017, stems from a critical discrepancy where the product inside the packaging does not match its label. The issue affects Tibial Articular Surface Pads, used as cemented knee joint prostheses, specifically models 2303-3032 and 2303-5016, with batch numbers 17B621AX and 17B621AG. While some affected units were not sold in China, 62 units of batch 17B621AX were distributed. The regulatory framework involves the NMPA and the Shaanxi Provincial Food and Drug Administration, which is also conducting an investigation. As required actions, the company has notified affected customers to return the identified product batches for inspection. The NMPA encourages public supervision and requests any sightings of these recalled products be reported to the Shaanxi Provincial Food and Drug Administration.

Company: https://www.globalkeysolutions.net/companies/united-orthopedic-devices-co-ltd/3298a2cb-cd6d-42d2-a679-c521b33da6c1/