Six Recalls Released by NMPA

2020-09-18

On September 18, 2020, six overseas manufacturers voluntarily recalled five different medical devices. All these recalls are Class II Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.

Manufacturer	Product Name	Recall Classification		Recall Reason	Link
Biomet UK Limited	Exceed ABT Acetabular System	Class II	The etch of some products does not match the size on the label.		https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200918140133117.html
Biomet Orthopedics	Inverted shoulder joint system	Class II	Some products have the problems of incorrect assembly, incorrect number of shoulder pads and adapters in the package		href=”https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200904153902151.html” https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200904153902151.html
Maquet Critical Care AB	Critical Care Ventilator	Class II	There may be a problem with too short of the atomizing joint		https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200918111230142.html
Cook Incorporated	epoc BGEM	Class II	The retention time of some products in the body for more than four weeks may potentially increase the occurrence of catheter rupture and bend scale deposition, displacement or infection		https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200918111059162.html
Synthes GmbH	Locking Plates	Class II	One or more feature dimensions are out of tolerance		https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200918110925186.html
Datex-Ohmeda, Inc.	Ventilator	Class II	potential problems with oxygen sensors		https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20200918110742150.html