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

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.