China NMPA Product Recall - Bone drill

The National Medical Products Administration (NMPA) announced on December 10, 2015, a voluntary recall initiated by medical device manufacturer Howmedica Osteonics Corp. This action was reported by its distributor, Stryker (Beijing) Medical Devices Co., Ltd., on September 25, 2015. The core issue driving the recall was a customer complaint detailing the breakage of a bone drill, specifically Model 0932-0-000, Batch GW281208, three inches from its tip during a hip replacement surgery. The bone drill is intended for drilling and tapping procedures.

Under the NMPA’s regulatory oversight, it was confirmed that no affected products were imported into or sold within the Chinese market. Although the recall impacted regions such as the United Kingdom, Netherlands, Australia, Asia, New Zealand, Canada, Sweden, Spain, and Ireland, Stryker (Beijing) Medical Devices Co., Ltd. confirmed no domestic distribution. Consequently, beyond the mandatory reporting of the incident to the State Food and Drug Administration, the company indicated no further action would be taken in China. The NMPA requested that provincial, autonomous region, and municipal food and drug administrations reinforce their supervision and management of similar medical products to maintain public safety.