# China NMPA Product Recall - Knotless anchor bolts, OSTEORAPTOR™, dual fixing screw system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-endoscopy-division/887af0d8-cfa5-4357-8a93-b9bedc104c78/
Source feed: China

> China NMPA product recall for Knotless anchor bolts, OSTEORAPTOR™, dual fixing screw system by Smith & Nephew, Inc. Endoscopy Division published September 02, 2013. Recall level: . The National Medical Products Administration (NMPA) reported a voluntary recall initiated by Smith &

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Endoscopy Division is recalling knotless wire anchors and double-fixed screw systems.
- Company Name: Smith & Nephew, Inc. Endoscopy Division
- Publication Date: 2013-09-02
- Product Name: Knotless anchor bolts, OSTEORAPTOR™, dual fixing screw system
- Recall Reason: Pinholes or minor cracks (0.5mm-5.0mm) were found on the primary packaging bags of some products, thus compromising the aseptic packaging condition of the products.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Endoscopy Division
- Summary: The National Medical Products Administration (NMPA) reported a voluntary recall initiated by Smith & Nephew, Inc. Endoscopy Division, as communicated by its Chinese subsidiary, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on August 8, 2013. The recall primarily concerns knotless thread anchors, OSTEORAPTOR™ products, and specific dual fixation screw systems (CFDA (Imported) 2013 No. 3461648) due to packaging integrity issues. The main violation was the discovery of pinholes or minor cracks on the primary packaging bags, which could compromise the sterile barrier of the products.

This global recall did not affect products actively marketed or sold to patients in China. In China, 307 pieces were imported exclusively as samples for product registration testing. Of these, 37 pieces were consumed during testing, and 270 remain in stock. These items were distinctly labeled for "Non-clinical use" and were not distributed for commercial purposes. The regulatory framework involves the NMPA's oversight of medical devices. As a required action, the remaining affected samples will continue to be stored in the sample warehouse. Furthermore, the NMPA has directed all provincial food and drug administrations to enhance their supervision and management of similar medical devices to uphold product safety standards.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc-endoscopy-division/df034cb9-0899-4c11-a410-b8102d0e5fec/