The Recall Desk

Manufacturer

Avitus Orthopaedics, Inc.

2 recalls in our database name Avitus Orthopaedics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-04-03

Of the 2 recalls from Avitus Orthopaedics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1047-2019·2019-04-03

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2019·2019-04-03

    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
    Medical Device
    Distribution
    Distributed nationwide