Be Careful! What Kind of Mistakes Lead to Recalls in China?

From May 21 to 26, 2021, seven overseas manufacturers voluntarily recalled different medical devices.Most of the recalls involved Class III products.. Detailed information about the manufacturers and affected products are listed in the table below. Inspirative Medical can help medical device/IVD manufacturers comply with the increasing requirements of post-market surveillance in China.

China’s post-market surveillance requirements
Handling recall, AE, SAE in China
Legal agent responsibilities

Manufacturer	Product Name	Recall Classification	Recall Reason
Ethicon LLC	INTERCEED Absorbable Adhesion Barrier	Class III	For the specific models and batches of products in a clinical study, the results of mid-term analysis showed that there was no significant difference in the incidence of adhesion between the test group and the control group
Ethicon SARL	GYNECARE INTERCEED Absorbable Adhesion Barrier	Class III
Zimmer GmbH	Metallic Intramedullary Nail	Class III	Mixed batches of CCD corner 130 and 125 products exist in specific models and specific batches.
W.L. Gore & Associates, Inc.	GORE PROPATEN Vascular Graft	Class III	There are label errors for specific models and batches of products.
St,Jude Medical Cardiac Rhythm Management Division	Pulse Generator	Class I	There are electrical faults in specific models and batches of products.
CooperVision Inc.	Soft Contact Lens	Class III	The product of a specific model and batch has the wrong mark of toric surface.
Abbott Ireland Diagnostics Division	ARCHITECT TRIGGER SOLUTION	Class III	Missing labels exist for certain types and batches of products.

Be Careful! What Kind Of Mistakes Lead To Recalls In China?

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