restor3d recalls

4 official recalls and safety alerts involving restor3d since 2022-05, 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 restor3d or the relevant agency.

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

    Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants,…

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of FL, CO.Official notice →
  3. 2026-08-26
  4. US
    Drugs & medicalClass II

    restor3d Inc. recalls Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030;…

    Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

    FDA · Devicerestor3d Inc.U.S. Nationwide distribution in the state of Texas.Official notice →
  5. 2022-05-11
  6. US
    Drugs & medicalClass II

    restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

    During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →
  7. US
    Drugs & medicalClass II

    restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual…

    Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →