# China NMPA Product Recall - APS Metal Plate & Screw System

Source: https://www.globalkeysolutions.net/records/china_product_recall/hess-shanghai-trading-co-ltd/0b9a1f38-6b33-4c45-bbb1-e21a9e3e2367
Source feed: China

> China NMPA product recall for APS Metal Plate & Screw System by Hess (Shanghai) Trading Co., Ltd. published September 01, 2020. Recall level: Level 3 Recall. On September 1, 2020, Apex (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: APS (Shanghai) Trading Co., Ltd. is voluntarily recalling its APS Metal Plate & Screw System.
- Company Name: Hess (Shanghai) Trading Co., Ltd.
- Publication Date: 2020-09-01
- Product Name: APS Metal Plate & Screw System
- Recall Level: Level 3 Recall
- Recall Reason: The product's fracture torsion angle does not meet the company's self-defined product technical requirements.
- Discovering Company: Apex (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Hess (Shanghai) Trading Co., Ltd.
- Summary: On September 1, 2020, Apex (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its APS Metal Plate & Screw System. This action, overseen by the National Medical Products Administration (NMPA) and announced via the Shanghai Municipal Drug Administration, stemmed from a national medical device spot check. The investigation revealed that the product's fracture torsion angle did not meet the company's self-defined technical specifications, indicating a potential issue with the device's structural integrity and performance. While specific inspection dates were not provided, the identification of this non-conformance during a routine spot check prompted the recall. The required action for Apex (Shanghai) Trading Co., Ltd., also referred to as Aps (Shanghai) Trading Co., Ltd., is to retrieve all affected units of the APS Metal Plate & Screw System. Details regarding the involved product models, specifications, and batches are available in the attached Medical Device Recall Event Report Form. This recall emphasizes the regulatory framework's role in ensuring manufacturers comply with established product quality and safety standards for medical devices.

Company: https://www.globalkeysolutions.net/companies/hess-shanghai-trading-co-ltd/6c24e066-8ddf-4ec4-aae2-88f853c654ce