# China NMPA Product Recall - Knee components

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/b54216e4-737c-46d2-94f3-26216c414f62/
Source feed: China

> China NMPA product recall for Knee components by Biomet Orthopedics published February 21, 2017. Recall level: Level II. Biomet Orthopedics, through its Chinese responsible unit Zimmer Biomet (Shanghai) Medical Internatio

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bonmei (Shanghai) Trading Co., Ltd. voluntarily recalls knee joint components.
- Company Name: Biomet Orthopedics
- Publication Date: 2017-02-21
- Product Name: Knee components
- Recall Level: Level II
- Recall Reason: Due to inadequate supplier clearance procedures between April 5, 2016 and September 1, 2016, Biomet Orthopedics is recalling certain batches of Vanguard PS open-box femoral condyle prostheses. Consequently, some batches of femoral condyle prostheses may have been incorrectly labeled as smaller or larger and/or the wrong side (right/left). The error information on the product label is easily identifiable. The estimated incidence rate is only 0.001% (1 in 1000 products). Therefore, Biomet Orthopedics is initiating a voluntary recall.
- Discovering Company: Bangmei (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: Biomet Orthopedics, through its Chinese responsible unit Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. (also referred to as Bangmei (Shanghai) Trading Co., Ltd.), initiated a voluntary Level II recall of specific batches of its Vanguard PS open-box femoral condyle prostheses. The recall, reported to the National Medical Products Administration (NMPA) on January 7, 2017, and published on February 21, 2017, addresses a critical labeling error. The primary issue involved incorrect product packaging labels, where some femoral condyle prostheses were erroneously marked with the wrong size (smaller or larger) or side (right/left). This problem stemmed from inadequate supplier clearance procedures identified between April 5, 2016, and September 1, 2016. While the estimated incidence rate was low at 0.001%, the potential for patient harm necessitated this action. Operating under the NMPA’s medical device recall framework (formerly CFDA), Biomet Orthopedics promptly recalled 3301 affected units globally, with 2322 units sold in China. The required action involved retrieving all unused affected products, which have since been successfully returned to the manufacturer. Fortunately, no adverse events or related complaints in China were reported concerning this labeling discrepancy.

Company: https://www.globalkeysolutions.net/companies/biomet-orthopedics/9bcf230e-90e5-4f4e-8673-6456e0ed8783/