NMPA Reports Active Recalls by Medtronic, Stryker, Boston Scientific and Others

On December 30, the National Medical Products Administration announced that nine companies, including Medtronic and Stryker, had voluntarily recalled some of their non-compliant products, such as pediatric oxygenation systems and hip joint prostheses.

The specific situation is as follows:

Intuitive Surgical, Inc. Initiates Voluntary Recall of Passive Instruments and Accessories for Endoscopic Surgical Instrument Control Systems

Intuitive Fosun Medical Device Technology (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is an error in the expiration date on the sterile sleeve packaging labels (shipping box and inner box labels). The manufacturer, Intuitive Surgical, Inc., is voluntarily recalling the inactive accessories of the Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control System (registration certificate number: GJXZZ20172222398).Recall level is Level 2.

Attachment:Medical Device Recall Incident Report Form

Medtronic Inc. Voluntarily Recalls AFFINITY PIXIE Oxygenation System for Pediatric Use

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues involving specific models and specific batches of products, Medtronic failed to properly track and control supplier Qosina's change control. The manufacturer, Medtronic Inc., voluntarily recalled the pediatric oxygenation system, AFFINITY PIXIE Oxygenation System (registration certificate number: Guo Medical Device Registration No. 20183102418).Recall level is Level 3.

Attachment:Medical Device Recall Incident Report Form

Stryker Howmedica Osteonics Corp Initiates Voluntary Recall of V40 Heads Hip Prosthesis

Stryker (Beijing) Medical Equipment Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a possibility that the white Tyvek paper lid on the outer packaging may detach from the sealed package. The manufacturer, Howmedica Osteonics Corp, a U.S.-based Stryker company, has initiated a voluntary recall of the V40 Heads hip prosthesis (registration certificate number: Guo Xi Zhi Jin 20163130078).Recall Level: Class III.

Attachment:Medical Device Recall Incident Report Form

DePuy (Ireland) Initiates Voluntary Recall of Non-Sterile Surgical Instruments for Shoulder Joints

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported that due to issues involving specific models and specific batches of products, where the diameter of the plug hole may be too small, DePuy (Ireland) initiated a recall of non-sterile surgical tools for shoulder joints (registration certificate code: GuoXieBei 20191439) produced by DePuy (Ireland).Recall level is Level II.

Attachment:Medical Device Recall Incident Report Form

Wright Medical Technology, Inc. voluntarily recalls the INBONE Total Ankle System

Ruiyi Medical Device (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a problem with incorrect products in the packaging. Wright Medical Technology, Inc., the U.S. Ruiyi Medical Technology Company, has voluntarily recalled the INBONE Total Ankle System (Registration Certificate No.: Guo Med Reg In 20153132065).Recall level is Level III.

Attachment:Medical Device Recall Incident Report Form

Smith & Nephew, Inc. Jet-X External Fixator Instrument System Voluntary Recall

Smith & Nephew Medical Products International Trade (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, the washer of the locking pin compressor was made from incorrect plastic material, which may wear and break during autoclave sterilization, causing potential failure of the compressor. Smith & Nephew, Inc. is voluntarily recalling the external fixator system tool Jet-X external fixator instrument system (Filing Certificate Code: GJXiaBei20151361).Recall Level: Class III.

Attachment:Medical Device Recall Incident Report Form

CooperVision Manufacturing Ltd Initiates Voluntary Recall of Multipurpose Solution for Hydrogen Peroxide Contact Lens Disinfectant

CooperVision Manufacturing Ltd Issues Voluntary Recall of Multipurpose Solution (Registration Certificate No.: Guo Med Reg In 20173221843), a Hydrogen Peroxide Contact Lens Disinfectant, Due to Bottles Manufactured with Unapproved High-Density Polyethylene (HDPE) Material Supplied by a Vendor. Reported by CooperVision Products Trading (Shanghai) Co., Ltd.Recall level is Level III.

Attachment:Medical Device Recall Incident Report Form

CooperVision Manufacturing Ltd. Multi-purpose solution

Voluntary Recall

CooperVision Products Trading (Shanghai) Co., Ltd. reported that due to the use of bottles manufactured with an unauthorized grade of high-density polyethylene (HDPE) material mistakenly supplied, CooperVision Manufacturing Ltd. voluntarily recalled the Multi-purpose Solution for contact lens care (Registration Certificate No.: Guo Med Reg In 20173221843).Recall level is Level III.

Attachment:Medical Device Recall Incident Report Form

Boston Scientific Corporation Initiates Voluntary Recall of Transend Guidewire

Stryker(Beijing)Medical Equipment Co., Ltd. reported that due to issues involving specific models and specific batches of products, certain batches of guidewires produced by Boston Scientific Corporation were sterilized at a facility not approved by Japan's Ministry of Health, Labour and Welfare. As a result, Boston Scientific Corporation initiated a voluntary recall of the Transend Guidewire (registration certificate number: Guo Medical Device Registration Approval 20173770330).Recall level is Level III.

Attachment:Medical Device Recall Incident Report Form