# China NMPA Product Recall - Burs disposable drill bits

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-xomed-inc/47e39da2-70ca-460c-b652-51f0875d25b7/
Source feed: China

> China NMPA product recall for Burs disposable drill bits by Medtronic Xomed, Inc. published May 23, 2019. Recall level: Level 3 Recall. Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a volu

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Xomed, Inc. is voluntarily recalling its single-use drill bits, Burs.
- Company Name: Medtronic Xomed, Inc.
- Publication Date: 2019-05-23
- Product Name: Burs disposable drill bits
- Recall Level: Level 3 Recall
- Recall Reason: The issue involved products with blunt tips that prevented proper cutting. Internal problem identification and analysis revealed that this was due to raw material issues arising from the switch to a new supplier, MSK.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Xomed, Inc.
- Summary: Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class III global recall for specific batches of its single-use drill bits Burs (National Medical Device Registration Certificate No. 20162214471). This recall was reported to the National Medical Products Administration (NMPA) on May 16, 2019, and publicly announced on May 23, 2019. The recall was prompted by customer complaints, totaling eleven cases globally, indicating that the product tip was blunt and failed to cut effectively during ENT, head, and neck surgical procedures. Internal investigations by Medtronic identified the root cause as a quality issue stemming from a change in the raw material supplier for these devices. Under the NMPA's regulatory framework for medical device safety, Medtronic's required corrective actions involve a proactive global recall to promptly inform affected customers and ensure the retrieval and destruction of all unused, non-conforming products from the market. While the recall is international in scope, the company confirmed that the identified affected product batches were not imported into or sold within the Chinese market. Therefore, no specific product retrieval or destruction actions for these batches are required within China, although Medtronic (Shanghai) Management Co., Ltd. fulfilled all necessary reporting obligations.

Company: https://www.globalkeysolutions.net/companies/medtronic-xomed-inc/6ab04f9c-4587-45b0-ab74-0dfb3aa38e32/