# China NMPA Product Recall - Power Tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/the-anspach-effort-inc/0b6c1a22-9737-4e9a-a113-8bebf8e93698/
Source feed: China

> China NMPA product recall for Power Tools by The Anspach: Effort, Inc. published September 13, 2017. Recall level: Level 3. The National Medical Products Administration (NMPA) issued a notice on September 13, 2017, concernin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: The AnspachEffort, Inc. proactively recalls powertrain systems.
- Company Name: The Anspach: Effort, Inc.
- Publication Date: 2017-09-13
- Product Name: Power Tools
- Recall Level: Level 3
- Recall Reason: The instruction manual (DFU) accompanying the above products does not include a recommended maintenance period.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: The Anspach: Effort, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice on September 13, 2017, concerning a voluntary Class III recall initiated by medical device manufacturer The AnspachEffort, Inc., and reported by its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall pertains to power systems designed for bone cutting and shaping, specifically for skull and spine applications. The primary issue identified was that the instructions for use (DFU) accompanying these products lacked a recommended maintenance period, which is crucial for product upkeep and user guidance. In response to this regulatory gap, The AnspachEffort, Inc. implemented a corrective action: all Power Tools products distributed after September 28, 2016, are now shipped with an updated DFU that includes the necessary maintenance schedule. The recall documentation clarifies that zero units of the affected products were sold or distributed in China, indicating the action primarily addresses global compliance standards and product information completeness rather than direct patient risk within the Chinese market.

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