Stryker Leibinger GmbH & Co. KG recalls

4 official recalls and safety alerts involving Stryker Leibinger GmbH & Co. KG 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 Stryker Leibinger GmbH & Co. KG or the relevant agency.

  1. 2024-05-29
  2. US
    Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for…

    Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

    FDA · DeviceStryker Leibinger GmbH & Co. KGUS Nationwide distribution.Official notice →
  3. 2024-05-15
  4. US
    Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas…

    Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

    FDA · DeviceStryker Leibinger GmbH & Co. KGNationwideOfficial notice →
  5. 2023-03-15
  6. US
    Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Device was shipped without having regulatory approval.

    FDA · DeviceStryker Leibinger GmbH & Co. KGDistribution of one unit only to a single customer in MA (USA)Official notice →
  7. 2022-03-09
  8. US
    Drugs & medicalClass II

    Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

    FDA · DeviceStryker Leibinger GmbH & Co. KGWorldwide distribution - US Nationwide.Official notice →