# China NMPA Product Recall - Absorbable bone anchors with sutures; meniscus suture systems; absorbable suture anchors; absorbable suture anchors and matching tools; TWINFIX Ultra HA Suture Anchor system; absorbable suture anchors with needles; absorbable curved guide suture anchors.

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/cbf661b7-34e5-490f-8b6f-962ab9bb0f86/
Source feed: China

> China NMPA product recall for Absorbable bone anchors with sutures; meniscus suture systems; absorbable suture anchors; absorbable suture anchors and matching tools; TWINFIX Ultra HA Suture Anchor system; absorbable suture anchors with needles; absorbable curved guide suture anchors. by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published September 17, 2020. Recall level: Level 2 Recall. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is voluntarily recalling: absorbable bone anchors with sutures; meniscus suture systems; absorbable suture anchors; absorbable suture anchors and related tools; TWINFIX Ultra HA Suture Anchor dual fixation screw system; absorbable suture anchors with needles; and absorbable flexible guide suture anchors.
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-09-17
- Product Name: Absorbable bone anchors with sutures; meniscus suture systems; absorbable suture anchors; absorbable suture anchors and matching tools; TWINFIX Ultra HA Suture Anchor system; absorbable suture anchors with needles; absorbable curved guide suture anchors.
- Recall Level: Level 2 Recall
- Recall Reason: Issues during the packaging process may include improper or incomplete sealing of the aseptic product packaging bags, potentially leading to a breach in the product's sterility barrier.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on September 17, 2020, following notification from the Shanghai Municipal Drug Administration (Report No. 2020-179). The recall stems from manufacturing deficiencies identified during the packaging process, where sterile product packaging bags were found to be improperly sealed or incomplete. This critical issue poses a risk of compromising the sterility barrier of the devices, which is essential for safe patient use. The affected products include a broad range of absorbable surgical devices such as absorbable bone anchors with sutures, meniscus suturing systems, various absorbable suture anchors (with and without accessories, needles, or flexible guides), and the TwinFIX Ultra HA Suture Anchor System. This action, overseen by the National Medical Products Administration (NMPA), aims to mitigate potential health risks by removing the non-conforming products from distribution. Detailed information on specific models and batch numbers is available in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-medical-products-international-trading-shanghai-co-ltd/838e3e3f-d561-4f82-9b98-419473c58276/