# China NMPA Product Recall - Manual tools for total knee replacement surgery (3-4 cruciate ligament-preserving joint specimens)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/04ad2986-161c-48fd-b334-313f883fc654/
Source feed: China

> China NMPA product recall for Manual tools for total knee replacement surgery (3-4 cruciate ligament-preserving joint specimens) by Smith & Nephew, Inc. Orthopedic Division published July 30, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Orthopaedics Division is recalling manual tools used in total knee replacement surgery.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2013-07-30
- Product Name: Manual tools for total knee replacement surgery (3-4 cruciate ligament-preserving joint specimens)
- Recall Reason: Regarding the manual tools for total knee replacement surgery (ACL-preserving joint specimens 3-4), one batch of this product was red (for deep disc tibial pad implantation) instead of blue (for ACL-preserving joint specimen implantation) due to the use of incorrect coloring material during the manufacturing process.
- 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) issued a notice regarding a voluntary recall initiated by Smith & Nephew, Inc. Orthopaedics Division. The recall, reported on July 12, 2013, and publicly announced on July 30, 2013, concerns specific manual tools for total knee replacement surgery (CFDA Import Registration No.: 20101101935). The primary issue stemmed from a manufacturing error where incorrect coloring materials were used for one batch (Model: 71430490, Batch: 12LM03798) of "Cruciate Ligament Preservation Joint Specimen 3-4." This batch was inadvertently produced in red, a color intended for deep disc tibial liner implantation, instead of the correct blue for cruciate ligament preservation joint implantation. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the local responsible unit, confirmed that the affected product batch was not imported into China and therefore had no impact on the Chinese market. The recall affected regions including Germany, the UK, France, and Dubai. Under the NMPA's regulatory framework, all provincial and municipal food and drug administration departments were instructed to enhance supervision and management of similar medical devices to ensure public safety.

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