China NMPA Product Recall - Locking screws and bone screws
Discuss this record with AI
Synthes GmbH, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its locking bone screws and bone screws due to an incorrect labeling issue. The company discovered that two specific batches of these medical devices may have been mislabeled with information pertaining to other products. This recall was formally reported to China's National Medical Products Administration (NMPA) on February 29, 2016, and subsequently published on March 11, 2016, under NMPA index JGXX-2016-10035. Significantly, Synthes GmbH confirmed that none of the affected products were imported or sold within mainland China. Consequently, no direct corrective actions were required from the company within the Chinese market. The recall's international scope included regions such as Australia, Hong Kong, New Zealand, France, Germany, the United Kingdom, Italy, Saudi Arabia, Sweden, and Peru. In response, the NMPA, operating under its regulatory framework, instructed provincial and autonomous region drug administrations to enhance their supervision and management of similar medical products to safeguard public health.
- Company
- Synthes GmbH
ID · f77319bf-926c-4923-8945-08a81d5a2bd1