# 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/ed5bb318-807a-477e-a87a-4d99a3518936/
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. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of The AnspachEffort, Inc.,

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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 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: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of The AnspachEffort, Inc., initiated a voluntary Class III recall of its Anspach Micromax Pneumatic Drill bone surgery device. This recall was reported to China's National Medical Products Administration (NMPA) on August 7, 2017. The primary reason for the recall was an omission in the device's Instructions for Use (IFU), which did not specify a recommended maintenance period. The Anspach Micromax Pneumatic Drill, registered under National Medical Device Registration Certificate 20152543543, is intended for cutting and grinding bone tissue. Crucially, no affected units of this specific model were sold or imported into the Chinese market. Therefore, no localized corrective actions were required in China. Globally, The AnspachEffort, Inc. addressed the issue by providing updated IFUs that include the recommended maintenance period for all pneumatic bone tissue surgical devices distributed after September 28, 2016. This measure ensures that users receive complete and essential information for the safe and effective operation of the device.

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