Z-1046-2019Class II

Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog...

Name: Z-1046-2019 Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog...
Creator: Avitus Orthopaedics, Inc.
Published: 2019-02-18
License: https://open.fda.gov/license/

Avitus Orthopaedics, Inc / initiated 2019-02-18 / Terminated / root cause: packaging

FDA source

Avitus Orthopaedics, Inc. began a recall of 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... on 2019-02-18. FDA classified it as Class II and gives the reason as "Breach in the sterile barrier pouch may compromise sterility of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1046-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-18
Posted: 2019-03-23
Terminated: 2020-04-22
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
Product code: KNW Instrument, Biopsy
Reason for recall: Breach in the sterile barrier pouch may compromise sterility of the device.
Root cause tag: packaging
FDA 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 [email protected] within 10 working days. If you have any questions, contact the Principal Consultant, MRC|X at 901-299-9390 or email: [email protected].
Quantity in commerce: 508 units
Distribution: US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Product codes and lots: Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22
Z-1047-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-22

Product code KNW

K152474Class IIAvitus Bone HarvesterAvitus Orthopaedics, Inc. / cleared 2015-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)