FDA Medical Device Recalls (openFDA)
Avitus Orthopaedics, Inc.: 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
- Recall number
- Z-1046-2019
- Recalling firm
- Avitus Orthopaedics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2019-02-18
- Posted
- not on file
- Terminated
- 2020-04-22
- Reason
- Breach in the sterile barrier pouch may compromise sterility of the device.
- Root cause
- Packaging process control
- Action
- The firm, Avitus, Initiated phone call to Distributors and Direct Hospital Sales on 2-18-2019, followed up with an Email that included a copy of the letter entitled "Urgent Medical Device Removal" and the response form with instructions. The letter requires the distributor/customer to acknowledge receipt of the letter, assess stock for potentially nonconforming lots, return potentially non-conforming product to Avitus, and to report any adverse event associated with potentially nonconforming material to Avitus. Complete and return the REMOVAL RETURN RESPONSE FORM via EMAIL TO neil@avitusortho.com within 10 working days. If you have any questions, contact the Principal Consultant, MRC|X at 901-299-9390 or email: ann.dunahoo@mrc-x.com.
- Quantity
- 508 units
- Distribution
- US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
- Lot, serial or model codes
- Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01
- 510(k) numbers
- ["K152474"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3011504993
- Firm city
- Farmington
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28