# China NMPA Product Recall - Absorbable nail repair fixation

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/166b70fa-b6b3-4409-bdb9-f5ab6317b6bc/
Source feed: China

> China NMPA product recall for Absorbable nail repair fixation by Covidien llc published December 20, 2023. Recall level: Level 2 Recall. Covidien LLC, in conjunction with Covidien Medical Devices International Trading (Shanghai) Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling absorbable nail repair fixation devices.
- Company Name: Covidien llc
- Publication Date: 2023-12-20
- Product Name: Absorbable nail repair fixation
- Recall Level: Level 2 Recall
- Recall Reason: The manufacturing error in the product in question resulted in low side seal strength of the aluminum foil bag, which may have led to the rupture of the sterile/moisture-proof barrier.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien LLC, in conjunction with Covidien Medical Devices International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its absorbable plug fixation devices. The National Medical Products Administration (NMPA) publicized this recall on December 20, 2023. The root cause for this action is a manufacturing error identified in the affected product batches. This error resulted in compromised side seal strength of the aluminum foil packaging, creating a risk that the sterile and moisture barrier could rupture. Such a breach compromises the device's sterility and integrity, potentially impacting patient safety. The recall, registered under National Medical Device Registration Certificate 20173130196, necessitates the removal of specific models, specifications, and batch numbers from the market, as detailed in the accompanying "Medical Device Notice." This action underscores the manufacturer's commitment to product quality and patient safety, operating under the regulatory oversight of the NMPA.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/