# China NMPA Product Recall - Metal plate system (periarticular locking plate system)

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-inc/52ff91de-18a8-4b54-a02d-f8f3395e58a2/
Source feed: China

> China NMPA product recall for Metal plate system (periarticular locking plate system) by Zimmer Inc. published March 30, 2015. Recall level: Class II Recall. On March 30, 2015, the National Medical Products Administration (NMPA) announced a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling its metal plate system (periarticular locking plate system).
- Company Name: Zimmer Inc.
- Publication Date: 2015-03-30
- Product Name: Metal plate system (periarticular locking plate system)
- Recall Level: Class II Recall
- Recall Reason: The threaded hole size of the affected product may exceed the nominal value.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Inc.
- Summary: On March 30, 2015, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by ZIMMER (Shanghai) Medical International Trading Co., Ltd. This action, reported by the company, addresses a critical quality issue with specific Metal Bone Plate Systems, identified as Periarticular Joint Locking Systems (Plate Systems) manufactured by Zimmer Inc. The affected products, bearing registration certificate number 3461086, are primarily used for temporary internal fixation and stabilization of bones following osteotomy or fracture around joints. The core violation centered on a manufacturing defect where the threaded hole size of certain units, including the "Distal radius palmar locking plate, left side 6.6mm" (Part Number 00-2358-014-04, Batch Number 62276042), was found to potentially exceed its nominal specifications. This deviation could compromise the structural integrity and efficacy of the device, posing potential risks in clinical application. Under the NMPA's regulatory framework, ZIMMER initiated this Class II recall to mitigate any patient safety concerns. The required action involves the return of all 14 affected units, specifically those imported and sold in China, directly to the manufacturer, Zimmer Inc., for proper disposition. This demonstrates the company's commitment to product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/zimmer-inc/05cec43c-1d05-4504-b41e-c83d04872937/