# China NMPA Product Recall - EXETER Total Hip System

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedica-osteonics-corp-a-us-based-orthopedic-company/0ae1b4c2-7100-4d07-9a3f-6b94476a1a0b/
Source feed: China

> China NMPA product recall for EXETER Total Hip System by Howmedica Osteonics Corp., a US-based orthopedic company. published September 24, 2025. Recall level: Level 3 Recall. Howmedica Osteonics Corp., a medical device manufacturer, has initiated a voluntary Class III recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp., a US-based orthopedic company, is voluntarily recalling hip prostheses.
- Company Name: Howmedica Osteonics Corp., a US-based orthopedic company.
- Publication Date: 2025-09-24
- Product Name: EXETER Total Hip System
- Recall Level: Level 3 Recall
- Recall Reason: Mixing of different batches and specifications
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Howmedica Osteonics Corp., a US-based orthopedic company.
- Summary: Howmedica Osteonics Corp., a medical device manufacturer, has initiated a voluntary Class III recall of its EXETER Total Hip System. This significant action was formally reported by Stryker (Beijing) Medical Devices Co., Ltd. The primary reason for this recall involves critical confusion between different production batches and specific product specifications of the hip prostheses. While the exact dates of an official inspection are not explicitly stated, the National Medical Products Administration (NMPA) publicly announced this event on September 24, 2025, underscoring the regulatory oversight.

Operating under the stringent medical device regulations of the NMPA, the recall is categorized as Class III, indicating a situation where use of or exposure to a product is not likely to cause adverse health consequences. This classification reflects the severity assessment of the identified product confusion issue. A key aspect of this particular recall is the confirmation that none of the affected EXETER Total Hip System products were imported into or distributed within the Chinese market. This mitigates potential direct patient safety risks within China. The comprehensive "Medical Device Recall Event Report Form" contains further granular details on the specific models, specifications, and batches involved, providing transparency in this important safety action. This proactive measure by Howmedica Osteonics Corp. demonstrates a commitment to addressing product integrity concerns and maintaining quality standards.

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