# China NMPA Product Recall - Plasma surgical system (trade name: Quantum); Plasma surgical system (trade name: Atlas)

Source: https://www.globalkeysolutions.net/records/china_product_recall/arthrocare-corporation/a24ffeeb-5615-4bd1-a428-a7963b4f7870/
Source feed: China

> China NMPA product recall for Plasma surgical system (trade name: Quantum); Plasma surgical system (trade name: Atlas) by ArthroCare Corporation published April 21, 2016. Recall level: . Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., as the responsible entit

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. voluntarily recalls plasma surgical systems.
- Company Name: ArthroCare Corporation
- Publication Date: 2016-04-21
- Product Name: Plasma surgical system (trade name: Quantum); Plasma surgical system (trade name: Atlas)
- Recall Reason: Testing revealed two issues: first, the packaging near the proximal end of the handle was ruptured; second, the pads were misaligned between the positive and negative electrodes. The packaging rupture did not pose an expected risk or adverse health consequence, and the pads or misaligned implants could be retrieved by extending the surgical time. However, a brief increase in temperature could have unintended effects on tissue. An investigation revealed that all affected products were expired; to avoid potential impacts, the company has decided to recall these batches.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: ArthroCare Corporation
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., as the responsible entity in China for products manufactured by ArthroCare Corporation, initiated a voluntary recall of its Plasma Surgical Systems (Trade Names: Quantum and Atlas). This recall, publicly reported on April 21, 2016, stemmed from issues discovered during product testing, which included packaging rupture near the handle's proximal end and misalignment of gaskets between the positive and negative electrodes. Additionally, all affected products were found to be expired. Although the packaging rupture was deemed to pose no expected risk, and misaligned pads could be retrieved during surgery, the company acknowledged potential implications like extended surgical time or localized temperature increases. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), the company implemented corrective actions. These involved drafting recall notices, informing distributors and subsequent healthcare facilities, collecting acknowledgment receipts, and ultimately retrieving all affected products to its Shanghai warehouse for return to the US factory. This proactive measure aimed to prevent potential impacts on patient safety and ensure compliance with medical device standards.

Company: https://www.globalkeysolutions.net/companies/arthrocare-corporation/2f1e96dd-1a31-4e2d-9128-2065ab94600c/