# China NMPA Product Recall - Spinal internal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-spine/8a8a2602-4058-4f1f-a32e-d41a69aa1703/
Source feed: China

> China NMPA product recall for Spinal internal fixation system by Zimmer Spine published July 13, 2015. Recall level: . ZIMMER SPINE, a medical device manufacturer, initiated a global voluntary recall of its Spinal Inter

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ZIMMER SPINE is recalling its spinal fixation system (brand name: Shiraz Java).
- Company Name: Zimmer Spine
- Publication Date: 2015-07-13
- Product Name: Spinal internal fixation system
- Recall Reason: There is a lack of steam sterilization validation to support the sterilization parameters mentioned in the English instruction manual.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Spine
- Summary: ZIMMER SPINE, a medical device manufacturer, initiated a global voluntary recall of its Spinal Internal Fixation System (trade names: Shiraz Java and Zimmer Natural Nail) due to significant quality and regulatory issues. The primary reasons for the recall were a lack of product certification and, more critically, the absence of steam sterilization validation to support the parameters outlined in the product's English instruction manual. This recall was reported to the National Medical Products Administration (NMPA), previously the CFDA, by Zimmer (Shanghai) Medical International Trading Co., Ltd., with the recall report dated June 22, 2015, and the NMPA publication on July 13, 2015. The affected products, approved under NMPA Medical Device (Imported) Approval No. 20093461886 (Revised), include various specifications of plugs, connecting blocks, and pedicle monoaxial screws designed for posterior spinal fixation. Notably, Zimmer (Shanghai) Medical International Trading Co., Ltd. confirmed that no units of the recalled product were imported into or sold within the Chinese market. In response, the NMPA mandated that all provincial, autonomous region, and municipal food and drug administrations strengthen their oversight and management of similar medical devices to ensure public safety.

Company: https://www.globalkeysolutions.net/companies/zimmer-spine/0b1979cd-3fff-4992-8ccb-fcbd09c1ffb7/