# China NMPA Product Recall - Patch (product name: PHYSIOMESH)

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-international-co-european-logistics-center/9bc98029-4732-4cc8-bd70-cf05fe817d4c/
Source feed: China

> China NMPA product recall for Patch (product name: PHYSIOMESH) by Johnson & Johnson International, c/o European Logistics Center published August 29, 2016. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls patches
- Company Name: Johnson & Johnson International, c/o European Logistics Center
- Publication Date: 2016-08-29
- Product Name: Patch (product name: PHYSIOMESH)
- Recall Level: Level II
- Recall Reason: Company research found that the recurrence or reoperation rate of the product in question was higher than the average recurrence rate of other patches. Ethicon's medical device safety team, in analyzing unpublished data from two large, independent hernia registry studies, found that the recurrence or reoperation rate of ETHICON PHYSIOMESH Flexible Composite Mesh patches used in laparoscopic abdominal wall hernia repair surgery was higher than the average recurrence rate of other patches.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson International, c/o European Logistics Center
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its ETHICON PHYSIOMESH Flexible Composite Mesh patches, as reported to the National Medical Products Administration (NMPA) on June 3, 2016, with the recall details published on August 29, 2016. This action was prompted by internal company research, which analyzed unpublished data from two independent hernia registries, the German Hernia Registry Study and the Danish Hernia Database DHDB. These studies indicated that the PHYSIOMESH patch exhibited a higher recurrence rate or reoperation rate compared to other patches when used in laparoscopic abdominal wall hernia repair surgeries, raising significant safety concerns.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-international-co-european-logistics-center/1ef45e4b-d2cd-4f02-a6cc-6272d0f5325b/