NMPA rolled call, GE, StryKer, Zimmer.
On June 1, the NMPA issued a recall notice for six medical devices, involving GE, Stryker, Zimmer, KARL STORZ and other well-known manufacturers.
- GE OEC Medical Systems, Inc. Voluntary recalled of mobile C-arm X-ray machines
GE Electric Medical Systems Trading Development (Shanghai) Co., Ltd. reported that the 9 “Image Intensifier could fall off due to being transported in an incorrect orientation and experiencing high impact force, manufacturer GE OEC Medical Systems, Inc. is voluntarily to recall mobile C-arm X-ray machine (NMPA (Import) 2013 No. 2301853, (NMPA (Import) 2013 No 20172300822, (NMPA (Import) 2013 No 20193060162).
The recall level is Level 2.
- STRYKER SPINE, Inc. voluntarily recalled the interbody fusion device
STRYKER (Beijing) Medical Device Co., LTD. reported that, due to the incorrect height marking of the Interbody fusion device, Stryker Spine voluntarily recalled the Ogival Interbody Cage-PEEK (NMPA (Import) No 20163131310).
The recall level is Level 3.
3. KARL STORZ SE & Co. KG voluntarily recalled laparoscopic passive instruments
KARL STORZ Endoscope (Shanghai) Co., Ltd. reported that due to the problem of inconsistent length of internal pipeline for specific batches of products, Manufacturer KARL STORZ SE & Co. KG voluntarily recalled Non-active Instruments for Laparoscopy (NMPA (Import) No 20172021816).
The recall level is Level 2.
- Zimmer Inc. voluntarily recalled knee joint prostheses
Zimmer (Shanghai) Medical International Trading Co., Ltd. reported that due to mislabeling of specific batches of products, the manufacturer, Zimmer Inc. voluntarily recalled the knee prosthesis (NMPA (Import) No 20153464235).
The recall level is Level 3.
- Arthrex, Inc. voluntarily recalled orthopedic surgical instruments
Arthrex Medical Devices (Shanghai) Co., LTD., reported that due to component errors during manufacturing, the manufacturer ，Arthrex, Inc. voluntarily recalled the Orthopedic Instruments (NMPA (Import) No 20212040521) .
The recall level is Level 3.
- CooperVision Inc. voluntarily recalled the soft hydrophilic contact lens
Cooper Vision reported that a case of soft hydrophilic contact lens blister containing foreign particles was found, and the manufacturer Cooper Vision Inc. actively recalled of soft hydrophilic contact lens (National instrument injection 20183221999).
The recall level is Level 3.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
