# China NMPA Product Recall - Powered system mobile phone interface Powered system accessories

Source: https://www.keypedia.com/records/china_product_recall/the-anspach-effort-inc/bc6a4364-f77d-42c6-b6e9-c287661e1757
Source feed: China

> China NMPA product recall for Powered system mobile phone interface Powered system accessories by The Anspach: Effort, Inc. published September 13, 2017. Recall level: Level 3. The AnspachEffort, Inc., facilitated by its agent Johnson & Johnson (Shanghai) Medical Devices Co., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: The AnspachEffort, Inc. is proactively recalling the powertrain's mobile phone interface.
- Company Name: The Anspach: Effort, Inc.
- Publication Date: 2017-09-13
- Product Name: Powered system mobile phone interface Powered system accessories
- Recall Level: Level 3
- Recall Reason: Since the instruction manual (DFU) accompanying the above products does not include a recommended maintenance period, all Powered system accessories DFUs received after September 28, 2016, include a recommended maintenance period.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: The Anspach: Effort, Inc.
- Summary: The AnspachEffort, Inc., facilitated by its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a Class III voluntary recall of its power system mobile phone interface. This action, reported to the National Medical Products Administration (NMPA) on August 7, 2017, and published on September 13, 2017, stemmed from an identified deficiency: the product's instructions for use lacked a recommended maintenance period. The affected devices, manufactured in the USA, are utilized in neurosurgical, ENT, spinal, and skull surgeries. Critically, no affected product models or batches were imported into or sold within China. Consequently, under the NMPA's regulatory oversight, no specific corrective actions were required from the agent in the Chinese market. The manufacturer's corrective measure involved updating the instructions for use to include the necessary maintenance period for all relevant units globally, particularly those received after September 28, 2016, ensuring compliance and user safety.

Company: https://www.keypedia.com/companies/the-anspach-effort-inc/02a6764e-eb0b-4899-89b3-11e4f3cbcafc