The Recall Desk

FDA (Devices) recall action 89588

Nextremity Solutions recalled 2 products on 2022-03-16

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
2022-03-16
Critical
0
Units
47

Why these products were recalled

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

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

  • HighFDA (Devices)··2022-03-16

    Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect

    Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2022-03-16

    Surgical hammertoe instruments recalled for potential locking mechanism deformation

    The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
    Category
    Distribution
    9 states
Nextremity Solutions recalled 2 products on 2022-03-16 · The Recall Desk