# China NMPA Product Recall - Interbody fusion device

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-spine/66f9f302-87e9-4b2e-90cf-e99209399e66/
Source feed: China

> China NMPA product recall for Interbody fusion device by Zimmer Spine published April 21, 2016. Recall level: Level 2 Recall. Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., representing manufacturer Zimmer 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls interbody fusion devices.
- Company Name: Zimmer Spine
- Publication Date: 2016-04-21
- Product Name: Interbody fusion device
- Recall Level: Level 2 Recall
- Recall Reason: Zimmer Spine received a report stating that upon opening product number SN3001-0-31404, lot number M1869208, the contents were found to be product number SN3001-0-31100, lot number M1869204. Due to the potential for packaging confusion between these two lot numbers, all unused products from these two specific lot numbers must be returned to Zimmer Spine.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Spine
- Summary: Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., representing manufacturer Zimmer Spine, initiated a voluntary Class II recall of intervertebral fusion devices. This action was reported to the National Medical Products Administration (NMPA) on March 7, 2016, and publicly announced on April 21, 2016. The recall was prompted by a significant product mix-up: an opened package identified as product number SN3001-0-31404 (batch M1869208) was discovered to contain the contents of product number SN3001-0-31100 (batch M1869204). This issue created a potential for confusion between these two distinct product batches. The affected products are Posterior Thoracolumbar Fusion Cages, with 167 units of SN3001-0-31100 and 82 units of SN3001-0-31404 having been imported into China, impacting global regions. In compliance with the NMPA's medical device regulatory framework, Zimmer Medical is required to retrieve all unused products from the two specified batches. These items must be returned to Zimmer Spine, the manufacturer, to rectify the mislabeling and uphold product integrity and patient safety.

Company: https://www.globalkeysolutions.net/companies/zimmer-spine/0b1979cd-3fff-4992-8ccb-fcbd09c1ffb7/