The Recall Desk

FDA (Devices) recall action 85642

Acuity Surgical Devices, LLC recalled 2 products on 2020-06-17

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
2020-06-17
Critical
0
Units
—

Why these products were recalled

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-06-17

    Acuity Surgical Devices Recalls A Link Z Intervertebral Body Fusion Devices

    Acuity Surgical Devices is recalling A Link Z Intervertebral Body Fusion Devices due to a manufacturing issue that may prevent vertebral body bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2020-06-17

    Acuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect

    Acuity Surgical Devices is recalling 178 A Link Z intervertebral body fusion devices because a manufacturing issue prevented bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x
    Category
    Distribution
    11 states