The Recall Desk

FDA (Devices) recall action 89983

restor3d Inc. recalled 3 products on 2022-05-11

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2022-05-11
Critical
0
Units
27

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2022-05-11

    Evans Wedge Disposable Trials Orthopedic Surgical Instruments Recalled for Mixed Parts

    restor3d Inc. is recalling Evans Wedge Disposable Trials orthopedic surgical instruments because parts were mixed into other lots during relabeling for extended shelf-life. The recall affects devices distributed nationwide across seven states.

    Product
    Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2022-05-11

    Cervical Cage Trial Kit Recalled for Incorrect Size Labeling

    restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit because the product was labeled as Small Footprint when it is actually Medium. The lot was distributed nationwide across seven states.

    Product
    Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2022-05-11

    Evans Wedge Orthopedic Surgical Instrument Recalled for Parts Mixed During Rework

    restor3d Inc. is recalling 9 units of Evans Wedge Disposable Trials orthopedic surgical instruments because parts from different lots were mixed during a manufacturing rework and relabeling process.

    Product
    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
    Category
    Distribution
    7 states