# China NMPA Product Recall - Joint surgery kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/fbc3353a-4d64-466a-8018-62b39cb7c185/
Source feed: China

> China NMPA product recall for Joint surgery kit by HowmedicaOsteonics Corp. published November 18, 2019. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. voluntarily recalls joint surgery kits.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2019-11-18
- Product Name: Joint surgery kit
- Recall Level: Level 3 Recall
- Recall Reason: Stryker discovered that certain batches of 1½" orthopedic positioning pins (6541-4-515) were packaged incorrectly with %" orthopedic positioning pins (6541-4-575). These tools are primarily used during surgery to temporarily fix a universal tibial plateau template to the osteotomized proximal tibia. Additionally, they can be used to temporarily fix a MIS femoral measuring device to the distal femur after osteotomy.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Howmedica Osteonics Corp. for specific joint surgery tool kits (Registration Certificate Code: "国械备20171052号"). The recall was reported on October 22, 2019, and publicly issued on November 18, 2019. Stryker (Beijing) Medical Devices Co., Ltd., the product's agent, reported the primary issue as packaging confusion. Specifically, certain batches of 1½" orthopedic positioning pins (6541-4-515) were found to be packaged incorrectly, differing from ½" orthopedic positioning pins (6541-4-575). These tools are utilized during surgery for temporary fixation of tibial plateau templates and femoral measuring devices. Despite the identified packaging discrepancy, zero affected products were sold in China, mitigating direct impact within that market. Howmedica Osteonics Corp. is undertaking corrective actions through this voluntary recall to resolve the packaging inconsistency and ensure product integrity.

Company: https://www.globalkeysolutions.net/companies/howmedicaosteonics-corp/fb8e59ba-c29a-43ec-b211-2e0a543aa1f7/