# China NMPA Product Recall - Achilles tendon suture guide

Source: https://www.globalkeysolutions.net/records/china_product_recall/newdeal-sas/c68c62af-03b2-47b4-a2cc-0c956a370bf2/
Source feed: China

> China NMPA product recall for Achilles tendon suture guide by NEWDEAL SAS published December 07, 2016. Recall level: Level III. General Medical Devices (Shanghai) Co., Ltd., representing manufacturer Newdeal SAS in China, has in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: General Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its Achilles tendon suture guide.
- Company Name: NEWDEAL SAS
- Publication Date: 2016-12-07
- Product Name: Achilles tendon suture guide
- Recall Level: Level III
- Recall Reason: Because some models/lots of the Tyvek Achilles tendon suture guide may not maintain the integrity of their seal in the outer packaging within the claimed sterilization period, there is a possibility that this could affect the sterility of the outer surface of the inner packaging.
- Discovering Company: General Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: NEWDEAL SAS
- Summary: General Medical Devices (Shanghai) Co., Ltd., representing manufacturer Newdeal SAS in China, has initiated a Level III voluntary recall of its Achilles Tendon Suture Guide (Model 119700, Batch F4FV). This action, reported to the National Medical Products Administration (NMPA) on September 5, 2016, addresses a potential issue with the sterile outer packaging. The company discovered that the packaging might not maintain its seal integrity throughout the product's claimed sterilization period, thereby potentially affecting the sterility of the inner packaging's outer surface.

Despite this concern, internal verification has confirmed that the medical device itself remains sterile within its inner packaging, and no adverse events or complaints have been reported regarding this issue. The recall affects 155 units globally, with 142 units sold in China. As part of the corrective actions, General Medical Devices (Shanghai) Co., Ltd. is conducting a comprehensive safety assessment of the identified risk. Additionally, all relevant distributors have been instructed to inspect their inventory and arrange for the return of any affected products. This proactive recall demonstrates the company's commitment to product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/newdeal-sas/6be0139b-8aa1-42b4-a44a-d1d60a2aa86f/