# China NMPA Product Recall - Anspach Micromax Pneumatic Drill, a pneumatic bone tissue surgical device

Source: https://www.globalkeysolutions.net/records/china_product_recall/the-anspach-effort-inc/a498578c-2953-4fb5-9272-4252c25a9868/
Source feed: China

> China NMPA product recall for Anspach Micromax Pneumatic Drill, a pneumatic bone tissue surgical device by The Anspach: Effort, Inc. published September 13, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a notice regarding a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: The AnspachEffort, Inc. is voluntarily recalling its pneumatic bone surgery equipment.
- Company Name: The Anspach: Effort, Inc.
- Publication Date: 2017-09-13
- Product Name: Anspach Micromax Pneumatic Drill, a pneumatic bone tissue surgical device
- Recall Level: Level 3 Recall
- Recall Reason: Since the instruction manual (DFU) accompanying the above products does not include a recommended warranty period.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: The Anspach: Effort, Inc.
- Summary: The National Medical Products Administration (NMPA) published a notice regarding a voluntary Class III recall initiated by The AnspachEffort, Inc., through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, officially published on September 13, 2017, concerned the Anspach Micromax Pneumatic Drill, a device used for bone tissue surgery. The core issue identified was that the device's instructions for use (DFU) did not include a recommended maintenance period.

In response, the manufacturer stated that an updated version of the instructions, incorporating the necessary warranty period information, would accompany all pneumatic bone tissue surgical devices shipped after September 28, 2016. Crucially, the detailed recall report, dated August 7, 2017, confirmed that no units of the specific affected product models were imported or sold within China. Therefore, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. concluded that no direct corrective actions were necessary for the Chinese market, as the identified documentation deficiency did not affect products distributed in their region. This action reflects the company's adherence to regulatory standards.

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