# China NMPA Product Recall - Metal intramedullary nail

Source: https://www.keypedia.com/records/china_product_recall/zimmer-gmbh/64c4da62-4a26-4b61-8729-59fec4444771
Source feed: China

> China NMPA product recall for Metal intramedullary nail by Zimmer GmbH published August 29, 2016. Recall level: Level II. Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., in coordination with manufacturer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls intramedullary nails.
- Company Name: Zimmer GmbH
- Publication Date: 2016-08-29
- Product Name: Metal intramedullary nail
- Recall Level: Level II
- Recall Reason: During product inspection, it was discovered that two specific batches of products may have been mixed up. A cephalic nail (product number 47-2493-303-11, batch number 2840845) with a diameter of 11.5mm, a length of 30cm, and a CCD angle of 130°, intended for the left leg, was mistakenly packaged in the same packaging as a cephalic nail (product number 47-2493-300-13, batch number 284046) with a diameter of 13mm, a length of 30cm, and a CCD angle of 125°, intended for the right leg, and vice versa.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer GmbH
- Summary: Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., in coordination with manufacturer Zimmer GmbH, initiated a voluntary global recall of specific batches of metal intramedullary nails. The National Medical Products Administration (NMPA) classified this as a Level II recall. The primary issue identified during product inspection was a critical packaging error: two distinct types of cephalic long nails (product numbers 47-2493-303-11 and 47-2493-300-13), intended for femur fracture fixation, were found to be mispackaged. This meant that the actual product's diameter, length, CCD angle, and designated leg (left or right) did not match the information on its packaging label. For instance, a nail intended for the left leg with specific dimensions was mistakenly placed in packaging for a right-leg nail with different specifications, and vice versa. The recall report was submitted on May 27, 2016, and publicly announced by the NMPA on August 29, 2016. In China, the company confirmed that no sales of the affected products had occurred domestically. A single imported product was immediately isolated within the warehouse, and all related sales activities were halted. Subsequently, all unused affected products were successfully returned to the manufacturer. Importantly, no adverse events, injuries, or fatalities related to this packaging discrepancy were reported within China.

Company: https://www.keypedia.com/companies/zimmer-gmbh/302d2715-92f8-4c43-b414-187e93b9b7ca