# China NMPA Product Recall - Total elbow joint prosthesis (trade name: Coonrad/Morrey)

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-inc/236fef4a-8fa0-45ba-b402-80e4027f9182/
Source feed: China

> China NMPA product recall for Total elbow joint prosthesis (trade name: Coonrad/Morrey) by Zimmer Inc. published September 09, 2016. Recall level: . The National Medical Products Administration (NMPA) issued an alert (Index No. JGXX-2016-10258) on S

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Inc. is recalling its total elbow joint prosthesis (trade name: Coonrad/Morrey).
- Company Name: Zimmer Inc.
- Publication Date: 2016-09-09
- Product Name: Total elbow joint prosthesis (trade name: Coonrad/Morrey)
- Recall Reason: A particular batch of products contained only one humeral liner in its packaging, requiring an additional product pack to complete the surgery. Without a backup, the surgery could not be completed.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Inc.
- Summary: The National Medical Products Administration (NMPA) issued an alert (Index No. JGXX-2016-10258) on September 9, 2016, regarding a recall initiated by Zimmer Inc. This recall involved a specific batch (62811341) of its Coonrad/Morrey Total Elbow Prosthesis, distributed in China by Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. The primary issue was that the product package for this batch contained only one humeral bushing instead of the two required for a complete surgical procedure. This deficiency meant that an additional product pack would be necessary during surgery, or the procedure could not be completed.The manufacturer, Zimmer Inc., proactively issued a voluntary recall notice. Crucially, the company confirmed that the affected batch of hinge screws and extra small bushings was not sold within the Chinese market, and no related complaints originated from China. Consequently, specific corrective actions for product retrieval in China were deemed not applicable. Under the regulatory oversight of the NMPA, provincial Food and Drug Administrations were instructed to enhance their supervision and management of similar medical devices. This NMPA document, referencing an August 29, 2016, Medical Device Recall Event Report, underscores the importance of accurate product packaging and global medical device quality control.

Company: https://www.globalkeysolutions.net/companies/zimmer-inc/05cec43c-1d05-4504-b41e-c83d04872937/