# China NMPA Product Recall - Miniature oscillating saw

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/0c23ecfd-65a0-4d81-a907-e78469802788/
Source feed: China

> China NMPA product recall for Miniature oscillating saw by Medtronic Inc. published August 30, 2016. Recall level: Level II. On August 30, 2016, the National Medical Products Administration (NMPA) publicized a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls miniature oscillating saws
- Company Name: Medtronic Inc.
- Publication Date: 2016-08-30
- Product Name: Miniature oscillating saw
- Recall Level: Level II
- Recall Reason: Medtronic initiated this recall because it identified a potential for liquid leakage into the instrument's interior during testing of the sagittal microsaw's rocker arm housing seal. However, no reports of liquid leakage from sagittal microsaws have been received on the market. Further testing to assess this potential risk revealed that the gravity-displacement sterilization cycle described in the Medtronic Integrated Surgical Power System (IPC®) instruction manual may be insufficient to ensure the sterility of internal components should external liquids seep through the rocker arm housing seal into the instrument.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On August 30, 2016, the National Medical Products Administration (NMPA) publicized a voluntary Class II recall initiated by Medtronic (Shanghai) Management Co., Ltd. The recall, reported by Medtronic on June 20, 2016, addresses a critical issue identified in their Miniature Oscillating Saw (models ES310, ES300).

Medtronic's internal testing revealed a potential problem with the sealing of the saw's housing, which could allow liquid to seep into the device. Further assessments indicated that if liquid ingress occurs, the gravity displacement sterilization cycle detailed in the Medtronic Integrated Surgical Power System (IPC®) instruction manual might be insufficient to ensure the sterility of internal components. This poses a significant risk as the product, intended for cutting tissue and bone during surgery, must maintain sterility.

The affected products include specific serial numbers in China: P06120725, P06122026, P06237044, and P06238411, with four units sold in China as part of a global recall. To mitigate this potential patient safety risk, Medtronic has implemented corrective actions. The company issued notification letters to all affected distributors and hospitals, instructing them to return all identified products to Medtronic. This proactive measure aims to prevent any non-sterile devices from being used in surgical procedures.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/