# China NMPA Product Recall - Twinfix screw system, rotator cuff double-row fixation screw (product name: FOOTPRINT), twinfix screw (product name: TWINFIX ULTRAPK), tendon and ligament fixation anchor (product name: FOOTPRINT Ultra).

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-endoscopy-division/5d998d28-7b75-4c5e-a544-a9671166282c
Source feed: China

> China NMPA product recall for Twinfix screw system, rotator cuff double-row fixation screw (product name: FOOTPRINT), twinfix screw (product name: TWINFIX ULTRAPK), tendon and ligament fixation anchor (product name: FOOTPRINT Ultra). by Smith & Nephew, Inc. Endoscopy Division published August 30, 2012. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced a Class I recall for four products man

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Endoscopy Division is recalling four products, including the Twinfix dual-fixation screw system.
- Company Name: Smith & Nephew, Inc. Endoscopy Division
- Publication Date: 2012-08-30
- Product Name: Twinfix screw system, rotator cuff double-row fixation screw (product name: FOOTPRINT), twinfix screw (product name: TWINFIX ULTRAPK), tendon and ligament fixation anchor (product name: FOOTPRINT Ultra).
- Recall Level: Level 1 Recall
- Recall Reason: In rare cases, the aseptic packaging of a product may develop pinhole-like damage due to vibration during transportation and friction between the anchor and the packaging bag, thereby compromising the aseptic packaging condition of the product.
- 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) announced a Class I recall for four products manufactured by Smith & Nephew, Inc. Endoscopy Division, including the Twinfix Double Fixation Screw System and FOOTPRINT Ultra tendon and ligament fixation anchors. This voluntary recall, initiated by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. on August 14, 2012, was prompted by potential pinhole-like damage to the sterile packaging tape. This damage, resulting from vibration and friction between the anchors and the packaging during transportation, compromised the aseptic condition of the medical devices. A Class I recall indicates a high probability of serious adverse health consequences.

Under the NMPA's regulatory framework, provincial and municipal food and drug administrations were directed to supervise the recall. Smith & Nephew's required actions included immediately isolating and prohibiting the sale or use of all 7229 clinically unused products. Additionally, distributors and sales representatives were tasked with informing hospitals to return any affected products. Smith & Nephew committed to replacing these returned items with new, equivalent models. All recalled products were to be consolidated at Smith & Nephew's Shanghai warehouse before being returned to the company's U.S. Endoscopy Division for final processing.

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