# China NMPA Product Recall - Surgical head frame

Source: https://www.globalkeysolutions.net/records/china_product_recall/integra-lifesciences-corporation/5dfb9ec3-4cac-49f1-94a4-150ea1cd9c6f/
Source feed: China

> China NMPA product recall for Surgical head frame by Integra LifeSciences Corporation published March 10, 2015. Recall level: Level II. Integra LifeSciences Corporation initiated a voluntary Class II recall for its MAYFIELD™ Cranial Sta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: In response to the voluntary recall of surgical head frames by InnoCare (Shanghai) Marketing Consulting Co., Ltd.
- Company Name: Integra LifeSciences Corporation
- Publication Date: 2015-03-10
- Product Name: Surgical head frame
- Recall Level: Level II
- Recall Reason: The locking handle of the 360-degree base connector of the surgical head frame may malfunction during use and fail to lock. The reason is that the gap between the inner diameter of the cam rod and the matching rod is too large, resulting in excessive tension on the cam rod and failure to lock.
- Discovering Company: Inlujia (Shanghai) Marketing Consulting Co., Ltd.
- Manufacturing Company: Integra LifeSciences Corporation
- Summary: Integra LifeSciences Corporation initiated a voluntary Class II recall for its MAYFIELD™ Cranial Stabilization Products, specifically surgical headrests, as published by the National Medical Products Administration (NMPA) on March 10, 2015. The recall addresses a critical manufacturing defect where the locking handle of the 360-degree base connector may malfunction during use, failing to secure properly. Investigations revealed the root cause to be an excessive gap between the cam rod's inner diameter and its mating rod, reducing contact and causing excessive tension that prevents proper locking. Affected products include all batches manufactured and distributed globally since October 2006. While 71 malfunction complaints were received internationally, no patient injuries or adverse consequences were reported, and no complaints were received for products sold in China. Under the NMPA's regulatory oversight, Integra LifeSciences is implementing a corrective action plan. This involves sending recall notices to distributors. Subsequently, Integra will coordinate directly with end-users, such as hospitals and agents, to collect the affected devices for complimentary repair and stringent quality inspection before their return. This proactive recall aims to mitigate potential risks associated with the device's failure to lock securely during surgical procedures.

Company: https://www.globalkeysolutions.net/companies/integra-lifesciences-corporation/f4637c9b-aae0-4259-b30d-aab9d3bd97f3/