Nobel Biocare recalls

3 official recalls and safety alerts involving Nobel Biocare since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Nobel Biocare or the relevant agency.

  1. 2025-02-12
  2. US
    Drugs & medicalClass II

    Nobel Biocare recalls . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel…

    Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

    FDA · DeviceNobel BiocareU.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA,…Official notice →
  3. 2022-08-31
  4. US
    Drugs & medicalClass II

    Nobel Biocare recalls Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

    Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

    FDA · DeviceNobel BiocareU.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.:…Official notice →
  5. 2022-03-02
  6. US
    Drugs & medicalClass II

    Nobel Biocare Usa Llc recalls NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

    Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could…

    FDA · DeviceNobel Biocare Usa LlcWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →