The Recall Desk

FDA (Devices) recall action 87665

Nextremity Solutions recalled 2 products on 2021-05-05

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-05-05
Critical
0
Units
234

Why these products were recalled

Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended

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

1–2 of 2

  • ModerateFDA (Devices)··2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Distribution
    16 states
  • ModerateFDA (Devices)··2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Distribution
    16 states