Shi Lehui actively recalls hollow screw system product label information error

China Economic Network Beijing October 20 (Reporter He Wei) On October 15 Announcement. Report, Schleshui Medical Product International Trade (Shanghai) Co., Ltd. reports, due to specific models, specific batch products, existence of product label information errors, label display screws are all threads, but the real thing is partially threaded, manufacturer United States Xerox Hui Co., Ltd. Smith & Nephew, Inc. Pairs of Hollow Screw System Large Cann System (Registered Document Number: Statement 20153133339) Active Recall. The recall level is second.

This recalled product is a hollow screw system, a registration certificate or filing certificate code is a national operation. 20153133639, production enterprise for Smith & Nephew, Inc. US Schleshui Co., Ltd. company. This recall reason is a product label information error, and the label display screw is a full thread, but the actual is partially threaded.

Adult indications of this recall product are as follows: 1. Fracture in femoral cervical vesicles. (For high-packed femoral neck fractures, you need to be careful instead of internal fixation in replacement, to reduce the risk of fracture or femoral head ischemic necrosis); 2. Patients with branium or undergrowl of the femur, need to conduct appropriate Additional postoperative measures such as weight and except for other activities; 3. Hip artisan or malformed patients with odorary surgery; 4. Hip fusion; 5. 上 与 与 端 端Condyl steel plate treatment; 6. Tongzi stock backbone / neck fracture. 7. The 6.5mm and 8.0mm hollow screws in this product can be used for fracture fixation of adults and pediatric pelvic, short bones and long bones. Suitable for tibial fractures, tibial fractures, femoral condensation, pelvic fracture, acetabular fracture, palm fracture, tumor fracture, humerus fracture, pedicle fracture, middle palm and medium fracture, treatment with bone fracture; hip fusion and temporary Sexual drilling fixation.

This period involves the region and the country for Canada, the United States; the recall level is second; involving product production (or imported China) batch, number is 0; related to product model, specification 71106365s 6.5mm x 165mm hollow screw, full thread, stainless steel (Sterilization); Identification information (such as batch number) is 20GT39417; the number of sales involving products in China is 0. In addition, affected batch products have not been sold in China, which does not affect China.

施乐辉主动召回空心螺钉系统 产品标签信息错误

According to the China Economic Network reporter found, 2020 Global Medical Devices Company is ranked 23rd, and there is no change in rankings in 2019, revenue reached 5.138 billion US dollars.