China NMPA Product Recall - Non-cemented stem

Smith & Nephew Surgical Implants (Beijing) Co., Ltd. initiated a voluntary Class III recall of specific batches of its uncemented handles, components used in cementless hip prostheses. The National Medical Products Administration (NMPA) published this recall notice on November 23, 2016, based on the company's report dated November 16, 2016. The recall was prompted by a manufacturing process issue resulting in the peeling of the vacuum plasma spray coating on these devices. This critical defect was observed within the product packaging before use, raising concerns about product integrity. The recall impacts 169 units of affected products in China, specifically models A2104 and A2105, identifiable by various batch numbers including 16AB00351 and 16CB00614. Operating under the regulatory oversight of the NMPA, which references CFDA Approval No. 20143461200, the company's required action involved sending written notifications to all affected customers. These notifications requested the return of any unused defective products, aiming to mitigate potential risks and uphold medical device quality standards.