# China NMPA Product Recall - Knee prosthesis - tibial pad

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-trabecular-metal-technology-inc/7aae6b18-270b-478d-85b3-f945d65ea733/
Source feed: China

> China NMPA product recall for Knee prosthesis - tibial pad by Zimmer Trabecular Metal Technology, Inc. published February 26, 2019. Recall level: Level 2 Recall. Zimmer Trabecular Metal Technology, Inc., through its agent Zimmer (Shanghai) Medical International 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Trabecular Metal Technology, Inc. is issuing a proactive recall of its knee prosthesis – the tibial pad.
- Company Name: Zimmer Trabecular Metal Technology, Inc.
- Publication Date: 2019-02-26
- Product Name: Knee prosthesis - tibial pad
- Recall Level: Level 2 Recall
- Recall Reason: An investigation has determined that the seven batches may have been mixed together, resulting in a mismatch between the products in the packaging and those indicated on the labels.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Trabecular Metal Technology, Inc.
- Summary: Zimmer Trabecular Metal Technology, Inc., through its agent Zimmer (Shanghai) Medical International Trading Co., Ltd., initiated a voluntary Class II recall of specific batches of its knee prosthesis – tibial pad. The recall, publicly reported by the National Medical Products Administration (NMPA) on February 26, 2019, with a report date of February 13, 2019, addresses a critical product-label mismatch.
The primary issue identified was that seven specific batches of the tibial pads might have been inadvertently mixed during production or packaging. This mixing resulted in a discrepancy between the product actually contained within the packaging and the details provided on the product label. Such a mismatch could potentially lead to incorrect product usage, although the recall level suggests the probability of serious adverse health consequences is remote or temporary.
While the recall originated from Zimmer Trabecular Metal Technology, Inc. and was conducted by Zimmer Biomet, the affected product batches were not distributed or sold within China. The recall's scope specifically targets markets in the USA, Canada, Japan, and the European Union. The required action involves the comprehensive removal of these identified batches from distribution channels in the affected regions to prevent any potential risks associated with the labeling error. This proactive measure ensures patient safety and maintains regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/zimmer-trabecular-metal-technology-inc/5829618a-daa8-4c3b-bc35-5f4453ba8be5/