# China NMPA Product Recall - dental drills

Source: https://www.globalkeysolutions.net/records/china_product_recall/institut-straumann-ag/230ad0a6-e5a2-438c-bec7-b55e7ab775bb/
Source feed: China

> China NMPA product recall for dental drills by Institut Straumann AG published December 15, 2016. Recall level: Level 3. The National Medical Products Administration (NMPA) published a Class III voluntary recall notice on

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Institut Straumann AG voluntarily recalls dental drill bits.
- Company Name: Institut Straumann AG
- Publication Date: 2016-12-15
- Product Name: dental drills
- Recall Level: Level 3
- Recall Reason: The product's shaft diameter is larger than the nominal value of 2.35mm, which may prevent it from connecting to dental handpieces from certain brands.
- Discovering Company: Straumann (Beijing) Medical Device Trading Co., Ltd.
- Manufacturing Company: Institut Straumann AG
- Summary: The National Medical Products Administration (NMPA) published a Class III voluntary recall notice on December 15, 2016, regarding dental drill bits manufactured by Institut Straumann AG. This recall, reported by Straumann (Beijing) Medical Device Trading Co., Ltd. on December 7, 2016, addresses a critical product issue. The primary concern is that the shank diameter of the dental drill bits (Registration Certificate Number: CFDA (Imported) 2014 No. 2550128) is 2.35mm larger than its specified nominal value. This dimensional discrepancy could prevent the drill bits from properly connecting with certain brands of dental handpieces, potentially compromising their intended use during oral implantation procedures. Under the NMPA's regulatory framework, Institut Straumann AG and its Chinese responsible unit initiated prompt corrective actions. All affected product batches, encompassing various models, were identified and confirmed to have not entered the market. The company has transferred these products to a designated warehouse isolation area. The required action involves the central destruction of all quarantined products, with the entire process being supervised by assigned personnel and thoroughly documented with photographs. This proactive internal recall ensures that no non-conforming products reach end-users, thereby upholding product safety and quality standards.

Company: https://www.globalkeysolutions.net/companies/institut-straumann-ag/9291a17f-9975-42ef-b11d-c854cc45f34b/