# China NMPA Product Recall - Hip prosthesis - polyethylene liner

Source: https://www.globalkeysolutions.net/records/china_product_recall/howmedicaosteonics-corp/33d08996-cdf9-417d-b804-7a1dc993a5a4/
Source feed: China

> China NMPA product recall for Hip prosthesis - polyethylene liner by HowmedicaOsteonics Corp. published December 11, 2019. Recall level: Level 3 Recall. Howmedica Osteonics Corp., through its reporter Stryker (Beijing) Medical Devices Co., Ltd., has ini

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Howmedica Osteonics Corp. voluntarily recalls hip prosthesis polyethylene liner.
- Company Name: HowmedicaOsteonics Corp.
- Publication Date: 2019-12-11
- Product Name: Hip prosthesis - polyethylene liner
- Recall Level: Level 3 Recall
- Recall Reason: The issue of certain batches of products lacking locking wires.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: HowmedicaOsteonics Corp.
- Summary: Howmedica Osteonics Corp., through its reporter Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class III recall of certain batches of its hip prostheses - polyethylene liners. Published by the National Medical Products Administration (NMPA) on December 11, 2019, this action addresses a manufacturing issue where specific product batches may be missing crucial locking wires. The affected medical device, identified by Registration Certificate No. 20173462014, is a vital component in hip replacement surgeries. A Class III recall indicates that the product's use is unlikely to cause adverse health consequences, yet the absence of locking wires could potentially compromise the long-term performance or stability of the hip prosthesis. Howmedica Osteonics Corp. is undertaking this recall to mitigate the potential defect and uphold patient safety and product integrity. Comprehensive details regarding the specific models, product specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This regulatory measure ensures that all affected devices are identified and removed from distribution.

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