# China NMPA Product Recall - Metal bone screws

Source: https://www.keypedia.com/records/china_product_recall/zimmer-inc/c03d05c7-616c-49c3-9b1f-816d61c6cc72
Source feed: China

> China NMPA product recall for Metal bone screws by Zimmer Inc. published July 06, 2016. Recall level: Level 3 Recall. Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., acting on behalf of Zimmer Inc., 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls metal bone screws.
- Company Name: Zimmer Inc.
- Publication Date: 2016-07-06
- Product Name: Metal bone screws
- Recall Level: Level 3 Recall
- Recall Reason: Zimmer Inc. has initiated a voluntary recall of certain batches of sterile packaged metal bone screws manufactured between February and March 2016. These screws were packaged in double sterile packaging, consisting of two plastic blister packs and a Tyvek seal, to ensure sterility. In some cases, minor damage may have been present in the inner blister pack. The assessment currently indicates that less than 10% of the affected products are affected. Because the outer blister pack is unaffected, the product's sterility remains intact until the outer blister pack is opened. The affected products were released between March and April 2016.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Inc.
- Summary: Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., acting on behalf of Zimmer Inc., initiated a voluntary Class III recall of specific batches of metal bone screws. This recall was reported to the National Medical Products Administration (NMPA) in May 2016 and publicly announced in July 2016. The affected products include certain models of Herbert 6.5mm Hollow Bone Screws (45mm, 75mm, and 90mm lengths) that were manufactured between February and March 2016 and subsequently released from March to April 2016. The main issue identified was a defect in the inner packaging material of the double sterile packaging, specifically minor damage to the inner plastic blister pack. Despite this, assessments confirmed that the outer blister pack remained intact, thereby maintaining the product's sterility until the outer packaging is opened. It is estimated that less than 10% of the affected products exhibited this damage. As a required action, all frozen inventory of the implicated products has been returned to the manufacturer, Zimmer Inc. Importantly, no complaints, adverse events, or deaths related to this specific packaging issue have been reported domestically or globally to date, highlighting a proactive measure by the company to ensure product quality and patient safety under NMPA oversight.

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