# China NMPA Product Recall - Triathlon TS Knee Revision Implants

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedica-osteonics-corp-a-us-based-orthopedic-company/5d179c0e-aa0d-463a-b661-ed72404d5cd2/
Source feed: China

> China NMPA product recall for Triathlon TS Knee Revision Implants by Howmedica Osteonics Corp., a US-based orthopedic company. published October 18, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp., a US-based orthopedic company, is voluntarily recalling revision knee prostheses.
- Company Name: Howmedica Osteonics Corp., a US-based orthopedic company.
- Publication Date: 2024-10-18
- Product Name: Triathlon TS Knee Revision Implants
- Recall Level: Level 3 Recall
- Recall Reason: The locking groove at the front end of the upper surface of the tibial plateau base exceeds the production standard.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Howmedica Osteonics Corp., a US-based orthopedic company.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Howmedica Osteonics Corp. for its Triathlon TS Knee Revision Implants. This action was reported by Stryker (Beijing) Medical Devices Co., Ltd. The main issue identified is a manufacturing deviation where the locking groove at the front end of the upper surface of the tibial plateau base exceeds established production standards, potentially affecting device performance. The recall operates under the regulatory framework of the NMPA, referencing National Medical Device Registration Certificate No. 20173136930. Significantly, the specific products involved in this recall were not imported into China, thus mitigating direct patient risk within the Chinese market. The primary required action is this voluntary Class III recall to address the non-conforming products, with further detailed information on specifications and batch numbers available in an attached Medical Device Recall Event Report Form. This demonstrates the manufacturer's commitment to product safety and adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/howmedica-osteonics-corp-a-us-based-orthopedic-company/efdccec1-2c1c-491a-9436-b07a5ea73169/