Stryker recalls two types of medical devices due to program error in surgical navigation system

China Economic Net, Beijing, August 19 (Reporter Sun Chenwei, Ma Xianzhen) The National Medical Products Administration website yesterday released an announcement on the voluntary recall of the orthopedic surgery navigation system by the American orthopedic surgery company MAKO Surgical Corp.. A few days ago, Stryker (Beijing) Medical Devices Co., Ltd. reported that due to the problem of program output errors involving specific models and specific batches of products, the manufacturer MAKO Surgical Corp., the American Orthopedic Surgery Company, has issued a report on the navigation system for orthopedic surgery (registration certificate number). : National Machinery Injection 20143015526) voluntarily recalled. The recall level is two.

The recalled product is a navigation system for orthopedic surgery. The registration certificate or record certificate code is National Machinery Injection 20143015526. The manufacturer is MAKO Surgical Corp., and the agent is Stryker (Beijing) Medical Instruments Co., Ltd. The reason for the recall was that Stryker discovered a problem related to the use of Mako's hip terminal actuator. The terminal receiver is connected to the most distal end of the Mako robotic arm, and its main function is to register the robot system, perform bone preparation (acetabular grinding), and implant the acetabulum (cupping). The proximal end of the end effector can be connected to two types of acetabular file handles, straight or eccentric. The choice of acetabular file handle is determined by the surgical approach and incision. The handle of the eccentric acetabular file has three directional grooves of 45 degrees, 90 degrees and 135 degrees.

Before using the Mako system, each end effector had established a specific number sequence to help the Mako system establish a tool control point (TCP) for each tool assembled to the end effector. On the handle of the eccentric acetabular file, each orientation slot of 45 degrees, 90 degrees and 135 degrees corresponds to a specific number sequence. Among the affected products, the TCP corresponding to the 90-degree slot of the eccentric acetabular file handle cannot match the parameter values preset in the Mako system software. During the preparation of the acetabulum for total hip arthroplasty, if the doctor uses the eccentric acetabular file handle and selects the 90-degree slot, the output error may cause the actual filing result to be inconsistent with the planned shape or depth. The 45-degree and 135-degree directional slot of the handle of the eccentric acetabular file and the handle of the straight acetabular file are not affected by this problem, and the straight and linear eccentric cupping handles do not have this problem.

my country has not imported the affected products (the country or region involved is the United States), and Stryker (Beijing) Medical Devices Co., Ltd. will not take other actions on the above products except for reporting to the State Food and Drug Administration.

In addition, the website of the National Medical Products Administration released Stryker Medical's voluntary recall of medical electric beds on the same day. A few days ago, Stryker (Beijing) Medical Devices Co., Ltd. reported that because the products involved are not suitable for personal use in the home environment, some countries sell them to individual users, which is beyond the scope of application. Stryker Medical, the manufacturer, voluntarily recalled medical electric hospital beds (registration number: National Machinery Injection 20192150339). The recall level is two.

The product recalled this time is a medical electric hospital bed. The registration certificate or filing voucher code is National Machinery Injection 20192150339. The manufacturer is Stryker Medical and the agent is Stryker (Beijing) Medical Equipment Co., Ltd. The reason for the recall is based on The scope of application, medical electric hospital beds are suitable for clinical institutions and operating in a medical environment, not suitable for personal use in a home environment, beyond the scope of application. The above-mentioned countries have sold medical electric hospital beds to individual users and therefore decided to initiate a product recall.

China also has not imported the affected products (the regions or countries involved are Argentina, Brazil, Chile, Colombia, Mexico). Except for reporting to the State Food and Drug Administration, Stryker (Beijing) Medical Devices Co., Ltd. will not Take other actions.

A reporter from China Economic Net found that Stryker (Beijing) Medical Devices Co., Ltd. was established on April 13, 2006, with a registered capital of 14.59557 million US dollars. Malida is the legal representative, chairman and general manager of the company. A wholly-owned subsidiary of Stryker (China) Co., Ltd.

Stryker is one of the world's leading medical technology companies, providing innovative products and services in orthopedics, medical and surgery, neurotechnology and spine. The company was founded in Michigan, USA in 1941. The current domestic business scope includes Class II, Class III, 6810 orthopedic (orthopedic) surgical instruments, 6821 medical electronic equipment, 6822 medical optical instruments, instruments and endoscopic equipment, etc. It has 29 production and R&D bases around the world, sells products in more than 100 countries and regions around the world, and has nearly 22,000 employees. In 2013, the global business exceeded 9 billion U.S. dollars and maintained business growth for more than 32 consecutive years, with an average annual growth rate of 19%. Stryker ranked ninth among the top 100 global medical device companies in 2019, with revenue of USD 13.6 billion and R&D expenditure of USD 862 million.