# China NMPA Product Recall - Reflection: Inner diameter of the acetabular inner wall 28mm, outer diameter 54mm, 20°, acetabular system.

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/7187ca50-5759-44db-9217-26735463d073/
Source feed: China

> China NMPA product recall for Reflection: Inner diameter of the acetabular inner wall 28mm, outer diameter 54mm, 20°, acetabular system. by Smith & Nephew, Inc. Orthopedic Division published December 19, 2013. Recall level: . The National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2013-1

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Orthopaedic Division is recalling its acetabular system.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2013-12-19
- Product Name: Reflection: Inner diameter of the acetabular inner wall 28mm, outer diameter 54mm, 20°, acetabular system.
- Recall Reason: Due to a potential internal process error, a production batch of acetabular liners may contain dimensional discrepancies, resulting in some liners failing to fit into the corresponding acetabular cup size. Other acetabular liners, however, may fit successfully. If the acetabular liner can be successfully installed and the surgery can be completed normally, there will be no prolongation of the operation time or any associated risks. If it cannot be installed during the operation, it is necessary to replace it with an acetabular liner of the same size, or to replace both the acetabular cup and the acetabular liner with a larger size, which may prolong the operation time.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Orthopedic Division
- Summary: The National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2013-10139) on December 19, 2013, concerning acetabular systems manufactured by Smith & Nephew, Inc. Orthopaedic Division and distributed in China by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall was initiated on November 29, 2013, following a report received on December 9th detailing a potential internal process error during production. The primary issue identified was dimensional discrepancies in a specific batch (12BM01836) of Reflection Acetabular Liners (Model 71742851). This defect could prevent the liners from fitting into their corresponding acetabular cups during hip replacement surgeries. Although successful installation posed no additional risks, fitting issues could necessitate replacing components or prolong surgical time. Under the NMPA's regulatory oversight, provincial food and drug administrations were tasked with strengthening supervision of such medical devices. Smith & Nephew's required actions included issuing a formal recall notice for the 37 affected units imported into China, promptly notifying distributors and healthcare facilities, and arranging for the collection of all recalled products. The company committed to providing equal numbers of replacement products and returning the affected items to Smith & Nephew USA for processing, projecting completion of the recall within one month due to the limited scope and available stock.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc-orthopedic-division/82243c50-18e1-44ef-893f-7042c1105847/