Recall Z-1047-2019— Avitus Orthopaedics, Inc.

Name: FDA recall Z-1047-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-18

Class II · Terminated

Class II FDA medical device recall by Avitus Orthopaedics, Inc., initiated 2019-02-18, terminated 2020-04-22. It names one FDA 510(k) clearance: K170539. 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. Reason: Breach in the sterile barrier pouch may compromise sterility of the device..

Recalling firm: Avitus Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-02-18
Terminated: 2020-04-22
Firm location: Farmington, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mmAvitus Orthopaedics, Inc.·cleared 2017-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.