Four Recalls Released by NMPA
On December 21, 2020, three overseas manufacturers voluntarily recalled four 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 |
| Covidien llc |
TA Autosuture Stapler & Loading Unit with DST Series Technology |
Class II |
May contain corrupted internal components |
| Biomet Orthopedics |
Vanguard 360 Revision Knee System |
Class II |
Incorrectly equipped components in the product packaging |
| Medtronic Inc. |
Clinician Programmer |
Class II |
The product has a software problem that prevents users from further upgrading the equipment |
| Lumbar external drainage and monitoring system |
Class II |
Products are sold without local regulatory approval in Singapore and South Korea |
