# China NMPA Product Recall - 876-460 Drill Stopper (Adjustable Drilling Stride); 6905712 Drill Bit Stopper (Adjustable Drilling Stride)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-sofamor-danek-usa-inc/0e15e57d-17e3-4152-9897-1f2e55ea6364/
Source feed: China

> China NMPA product recall for 876-460 Drill Stopper (Adjustable Drilling Stride); 6905712 Drill Bit Stopper (Adjustable Drilling Stride) by Medtronic Sofamor Danek USA, Inc. published May 02, 2012. Recall level: . Medtronic Sofamor Danek USA, Inc. initiated a voluntary recall of its 876-460 Stoppers (Adjustable D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Sofamor Danek USA, Inc. is recalling the 876-460 stopper (adjustable drill stroke device) and the 6905712 drill bit stopper (adjustable drill stroke device).
- Company Name: Medtronic Sofamor Danek USA, Inc.
- Publication Date: 2012-05-02
- Product Name: 876-460 Drill Stopper (Adjustable Drilling Stride); 6905712 Drill Bit Stopper (Adjustable Drilling Stride)
- Recall Reason: When used with power tools, the preset drill depth of the 876-460 stopper (adjustable drill stroke device) or the 6905712 drill stopper (adjustable drill stroke device) may be unexpectedly altered. If this unexpected adjustment occurs and the drill bit punctures the anterior or posterior cortex of the vertebral body, irreversible nerve damage may result. In such cases, immediate surgical intervention is necessary to repair damage to surrounding vascular/neural structures; the injury may include, but is not limited to, cervical-thoracic vascular puncture and/or spinal cord injury. Complications of such injuries can lead to irreversible damage and/or death. To date, there have been no reports of patient injury resulting from this injury.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Sofamor Danek USA, Inc.
- Summary: Medtronic Sofamor Danek USA, Inc. initiated a voluntary recall of its 876-460 Stoppers (Adjustable Drill Rangers) and 6905712 Drill Bit Stoppers (Adjustable Drill Rangers). This action, reported by Medtronic (Shanghai) Management Co., Ltd. and published by the National Medical Products Administration (NMPA) on May 2, 2012, addresses a critical safety concern. The primary issue involves the potential for unexpected changes in the preset drill bit depth when these stoppers are used with power tools during orthopedic surgery. Such a malfunction could lead to severe consequences, including the drill bit puncturing the vertebral body, potentially causing irreversible nerve damage, cervical-thoracic vascular puncture, or spinal cord injury. These injuries might necessitate immediate surgical intervention and could result in permanent damage or even death. While the risk is significant, no patient injuries related to this specific issue have been reported to date. The recall applies to all batches of the specified models, affecting products distributed in the USA, China, and other countries. The NMPA has mandated provincial Food and Drug Administrations to intensify their oversight of these medical devices to safeguard public health.

Company: https://www.globalkeysolutions.net/companies/medtronic-sofamor-danek-usa-inc/3dae4c6c-7556-4da9-a13d-28702559ac2b/