Six Recalls Released by NMPA
On November 30, 2020, six overseas manufacturers voluntarily recalled seven different medical devices. The recalls are Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. For more information about the recall products, please contact us via info@inspirativemed.com. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.
| Manufacturer |
Product Name |
Recall Classification |
Recall Reason |
| Boston Scientific Corporation |
Solyx SIS System |
Class III |
Products in South Korea are required to provide safety information to their customers |
| Stryker Medical |
ComfortGel SE Mattress |
Class III |
Incorrect labeling of the product |
| Ethicon SARL |
TVT Tension-Free Vaginal Tape System |
Class III |
Products in South Korea are required an on-site safety notice, requiring the enterprise to inform customers of the relevant notices |
| GYNECARE TVT ABBREVO Continence System |
| Stryker Instruments |
Small Bone Powered Surgical Systems |
Class II |
There may be cracks on the product drill |
| Synthes GmbH |
SynMesh |
Class III |
Incorrect identification of product label |
| Medtronic Inc. |
CSF Flow Control Shunts and Accessories |
Class II |
There are still some problems after the auxiliary protective cover is processed in the production process |
