China NMPA Product Recall - Hand-locking titanium plate system

Stryker GmbH initiated a voluntary Class III recall of its Hand Locking Titanium Plate System due to a critical material non-conformance, reported to the National Medical Products Administration (NMPA) on June 27, 2017, and published on September 27, 2017. The primary issue involved bone screws within the system being manufactured with an incorrect raw material grade; Grade IV titanium was used instead of the specified Ti6Al4V titanium alloy (Grade V). This material discrepancy could potentially affect the device's performance and integrity. Under the oversight of the NMPA, Stryker (Beijing) Medical Devices Co., Ltd., as the local agent, formally reported the manufacturer's global recall action. Although the affected product batches were distributed in several countries including the USA, Canada, Australia, and European nations, zero units of these specific non-conforming batches were sold or imported into the Chinese market. Consequently, beyond the formal reporting required by the regulatory framework, no further specific actions related to retrieving or managing affected products were necessary within China, ensuring compliance despite the absence of local market impact.