13 Recalls Released by NMPA

2020-08-21

From August 17 to 19 2020, 13 overseas manufacturers voluntarily recalled 21 different medical devices. These recalls include Class I, II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. Since China NMPA enhances the post-market surveillance, China Med Device can lead manufacturers in compliance with China regulations.

Link: https://www.nmpa.gov.cn/xxgk/chpzhh/index.html

No.	Manufacturer	Product Name	Recall Classification	Recall Reason
1	Zimmer Inc.	Total Elbow System	Class II	The number of sub-components in the package of specific model and specific batch is incorrect
2	Biomet UK LTD.	Oxford Partial Knee System	Class II	Specific models and batches of product packaging error
3	Arrow International, Inc.	Epidural Catheters Sets and Kits	Class II	Incorrect identification on specific models and batches of products, which shows incorrect expiration dates, may result in the use of expired devices, increasing the risk of infection or other complications
4	Smith & Nephew Inc. Endoscopy Division	Smith & Nephew Endoscopic Manual Instruments	Class II	Product packaging errors of specific models and batches resulting in the inconsistency of the outer package and the product.
5	Philips Medical Systems (Cleveland), Inc.	Computed Tomography System (5 devices with the same name)	Class III	The movement failure of the scanning bed may occur during the use of certain models of products
5	Philips Medical Systems (Cleveland), Inc.	X-ray computed tomography equipment	Class III
6	Boston Scientific Corporation	Captivator II Single-Use Polypectomy Snares	Class II	Failure to cut rings for specific models and batches of products may result in failure to cut and remove polyps.
		Captiflex Single-Use Polypectomy Snares
		Captivator Single-Use Polypectomy Snares
7	Smith & Nephew Orthopaedics AG	Hip Instruments	Class II	The product design problem leads to the small gap in the connection with the supporting tool, and thus the guide plate may break.
8	Stryker Medical	SV2 Electric Hospital Bed	Class II	The product is not suitable for personal use in the home environment, and it is sold to individual users in some countries, which is beyond the scope of application.
9	Becton Dickinson Medical(S) Pte. Ltd.	BD Precision Glide™ Needle	Class III	Specific models and batches of products may have unsealed packages and the packages may have been cut incorrectly
10	Physio-Control, Inc.	Automated External Defibrillator	Class III	For certain product models, the electrode packaging is not tightly sealed, which may cause the electrode piece to become dry, so that the defibrillator cannot detect the patient connection and provide invalid or no energy for the patient
11	Smith & Nephew, Inc.	Knee Instruments	Class III	Misprint on label of specific models and batches of products
11	Smith & Nephew, Inc.	Hip Instruments	Class III
12	Boston Scientific Corporation	Angiographic Catheter	Class I	The head end of specific product batches may become brittle due to external factors, resulting in head breakage during or before the operation of the head.
13	MAKO Surgical Corp.	Robotic Arm Interactive Orthopedic System	Class II	Program output error of specific models and batches of products