Z-1046-2019 Class II Terminated
FDA device recall Z-1046-2019 was initiated by Avitus Orthopaedics, Inc. on February 18, 2019 and is designated Class II. Reason for recall: Breach in the sterile barrier pouch may compromise sterility of the device. The recall status is terminated (terminated April 22, 2020). Affected quantity: 508 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 18, 2019
- Termination Date
- April 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 508 units
Product Description
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
Reason for Recall
Breach in the sterile barrier pouch may compromise sterility of the device.
Distribution Pattern
US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Code Information
Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01