# China NMPA Product Recall - dental drills

Source: https://www.globalkeysolutions.net/records/china_product_recall/institut-straumann-ag/ac4ae57e-8406-439e-aced-1ae466b089a6/
Source feed: China

> China NMPA product recall for dental drills by Institut Straumann AG published December 15, 2016. Recall level: Level 3 Recall. Institut Straumann AG, through its Chinese subsidiary, Institut Straumann (Beijing) Medical Device T

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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
- 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: Institut Straumann AG, through its Chinese subsidiary, Institut Straumann (Beijing) Medical Device Trading Co., Ltd., initiated a voluntary Class III recall of specific dental drill bits, as reported to the National Medical Products Administration (NMPA) on December 7, 2016, and publicly announced on December 15, 2016. The primary issue involved a manufacturing deviation where the product's shank diameter measured 2.35mm, exceeding its nominal value. This dimensional inaccuracy could prevent the drill bits from properly connecting with certain brands of dental handpieces, thereby hindering their intended use in oral implantation surgery for preparing Straumann dental implant systems. Operating under the regulatory oversight of the NMPA, the company proactively addressed this quality concern. Since none of the affected products had entered the market and were still held in the company's warehouse, the required corrective action involved isolating all implicated batches in a designated storage area. These products are slated for central destruction, with the entire process meticulously documented through photographic evidence to ensure proper disposal and prevent distribution. This voluntary recall demonstrates the company's commitment to product quality and patient safety.

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