China NMPA Product Recall - Miniature locking plate system for wrist

Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Wrist Miniature Locking Bone Plate System, as announced on June 4, 2019. The recall was prompted by a potential for weak seals in the aseptic packaging of the affected products. This issue compromises the sterility of the medical devices, posing a potential risk to patient safety. The recall specifically targets individually packaged sterile medical devices with product numbers 212000002 and 212000003, having an expiration date before April 30, 2024. Additionally, individually packaged sterile medical devices with product number 212000008, with an expiration date before April 30, 2029, are included. This action falls under the regulatory framework of the Shanghai Food and Drug Administration Medical Device Recall 2019-129, and the product holds Registration Certificate No. 20153461979. Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily removing these specific batches from the market to address the identified packaging integrity concerns. Further detailed information on affected models, specifications, and batches can be found in the accompanying Medical Device Recall Event Report Form.