The Recall Desk

FDA (Devices) recall action 82271

Avitus Orthopaedics, Inc. recalled 2 products on 2019-04-03

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
2019-04-03
Critical
0
Units
715

Why these products were recalled

Breach in the sterile barrier pouch may compromise sterility of the device.

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)··2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Distribution
    9 states