NMPA: Recall of 7 Batches of Medical Devices!
The following are the details of the seven product recalls issued by theNMPA on May 6:
01
Wright Medical Technology, Inc Voluntary Recall of ORTHOLOC 2.0/2.4 Forefoot Fracture System
Wright Medical Technology (Shanghai), Inc. reported that due to the incorrect products in the packaging due to the specific model and batch of products involved, the manufacturer Wright Medical Technology, Inc. actively recalled the Ankle Nail Plate System Ortholoc 2.0 / 2.4 Forefoot Fracture System (Registration Certificate No.: gxjz 20143136161). The recall level is level 3.
02
BioMerieux Inc actively recalled the Full-automatic Microbiological Identification and Drug Sensitivity Analyzer VITEK 2 System
Merier diagnostic products (Shanghai) Co., Ltd. reported that due to the problem of displaying wrong test results on LIS system due to specific models and batches of products, bio Merieux Inc., the manufacturer of BioMerier America Co., Ltd., actively recalled the Full-automatic Microbial Identification and Drug Sensitivity Analyzer VITEK 2 System (Registration Certificate No.: gxjz 20152220990). The recall level is level 3.
03
Smith & Nepew, Inc. initiated a recall of the TriGen InterTAN Hip Fracture Nailing System, a Joint Compression Interlocking Intramedullary Nailing System for the Hip
Smith & Nepew, Inc., the manufacturer of Smith & Nephew Medical products (Shanghai) Co., Ltd., actively recalled the Hip Joint Compression Interlocking Intramedullary Nail System Trigen Intertan Hip Fracture Nailing System (Registration Certificate No.: gxJz 20143135639) due to the problem of manufacturing errors involving specific models and batches of products. The recall level is level II.
04
Smith & Nephew, Inc. actively recalled Total Knee System Oxinum Femoral Implant and Total Knee System Journey II Knee System
Smith & Nephew (Shanghai), Inc. reported that due to the problem of incorrect product label information related to specific models and batches of products, Smith & Nephew, Inc., the manufacturer of the United States, took the initiative to recall the Total Knee System zirconium Niobium Alloy Femoral Condyle Implant and the Total Knee System Journey II Knee System (Registration Certificate No.: gxjz 20153132542, 20183130286). The recall level is level II.
05
Arrow International LLC actively recalled products such as Percutaneous Sheath Puncture Group and Central Venous Catheter Package
Talif Medical Device Trading (Shanghai) Co., Ltd. reported that due to the specific model and batch of products involved, the puncture needle seat cracked due to pressure during intubation. Arrow International LLC, the manufacturer, actively recalled the products such as Percutaneous Sheath Puncture Group and Central Venous Catheter Bag. The recall level is level 3.
06
Agfa NV actively recalled Medical Dry Film.
Agfa NV (Shanghai) Co., Ltd. reported that the manufacturer Agfa NV took the initiative to recall the Medical Dry Film (Filing Certificate Code: gxb 20200133, 20170743) due to the problem of writing error information on the RF tag due to the specific model and batch of products involved. The recall level is level 3.
07
Abbott Medical actively recalled the Disposable Magnetoelectric Positioning Pressure Monitoring Ablation Catheter Tacticathtm Contact Force Ablation Catheter, Sensor EnabledTM.
Abbott Medical Supplies (Shanghai) Co., Ltd. reported that due to a specific model and a specific batch of products, there was an error message displayed by the machine, which resulted in the pressure sensing function of the catheter being disabled, and the doctor was asked to replace the catheter product. Abbott Medical took the initiative to recall the Disposable Magnetoelectric Positioning Pressure Monitoring Ablation Catheter TactiCathTM Contact Force Ablation Catheter, Sensor EnabledTM (Registration Certificate No.: gxzj 20203010469). The recall level is three.
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