China NMPA Product Recall - Hip prosthesis - polyethylene liner

Howmedica Osteonics Corp., through its reporter Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class III recall of certain batches of its hip prostheses - polyethylene liners. Published by the National Medical Products Administration (NMPA) on December 11, 2019, this action addresses a manufacturing issue where specific product batches may be missing crucial locking wires. The affected medical device, identified by Registration Certificate No. 20173462014, is a vital component in hip replacement surgeries. A Class III recall indicates that the product's use is unlikely to cause adverse health consequences, yet the absence of locking wires could potentially compromise the long-term performance or stability of the hip prosthesis. Howmedica Osteonics Corp. is undertaking this recall to mitigate the potential defect and uphold patient safety and product integrity. Comprehensive details regarding the specific models, product specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This regulatory measure ensures that all affected devices are identified and removed from distribution.