China NMPA Product Recall - Knee revision prosthesis

Howmedica Osteonics Corp., represented by its agent Stryker (Beijing) Medical Devices Co., Ltd., initiated a global Class II recall for specific models and batches of its knee revision prostheses (NMPA Registration Certificate No. 20173466930). This action, reported on August 15, 2017, stemmed from the discovery that certain distal femoral pads—specifically four models (Size 2 left/right 10mm, Size 2 left/right 15mm)—protruded beyond the medial edge of their corresponding femoral components. These components are used in both revision and primary total knee arthroplasty. Under the regulatory framework of the National Medical Products Administration (NMPA), Howmedica Osteonics Corp. was required to implement corrective measures. In China, 35 affected distal femoral implants were identified. As all units remained in stock and had not been sold or distributed to users or healthcare facilities, no customer notification letters were necessary. The required action was to return these 35 implants to the manufacturing plant for proper disposal, ensuring no affected products reached the market.