# China NMPA Product Recall - Surgical head frame

Source: https://www.globalkeysolutions.net/records/china_product_recall/intergra-life-sciences-shanghai-co-ltd/a86bf549-1c26-4d54-ab33-550b1d51ff07/
Source feed: China

> China NMPA product recall for Surgical head frame by Intergra Life Sciences (Shanghai) Co., Ltd. published November 18, 2020. Recall level: Level 3 Recall. On November 18, 2020, Integra LifeSciences (Shanghai) Co., Ltd. initiated a voluntary regional corre

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intergra Life Sciences (Shanghai) Co., Ltd. has initiated a voluntary recall of surgical head frames.
- Company Name: Intergra Life Sciences (Shanghai) Co., Ltd.
- Publication Date: 2020-11-18
- Product Name: Surgical head frame
- Recall Level: Level 3 Recall
- Recall Reason: The illustrations in the product manual are inaccurate.
- Discovering Company: Intergra Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Intergra Life Sciences (Shanghai) Co., Ltd.
- Summary: On November 18, 2020, Integra LifeSciences (Shanghai) Co., Ltd. initiated a voluntary regional corrective action and Class III recall for its MAYFIELD 2000 Skull Clamp (model: A2000) surgical headrests. This action was prompted by an internal review which identified an incorrect fixation diagram in the product's Chinese instruction manual. The company determined the manual required revision to accurately depict the Mayfield headset fixation process. Under the oversight of the National Medical Products Administration (NMPA), specifically the Shanghai Municipal Drug Administration, the company confirmed that despite the error, the probability of serious injury was very low, and no complaints or adverse events had been reported due to the incorrect illustrations. Out of an abundance of caution, Integra LifeSciences decided to proceed with the corrective measures. The recall involves revising the instruction manual and withdrawing affected surgical headrests (Registration Certificate No.: 20150066) from the market. Detailed information on affected models and batches is available in a separate recall event report. This proactive step ensures product information accuracy and patient safety.

Company: https://www.globalkeysolutions.net/companies/intergra-life-sciences-shanghai-co-ltd/66d2e732-3cb7-442f-b531-a7694c950836/