Device 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
Z-1047-2019
Product summary
- Event
- Event 82271
- Status
- Terminated
- Classification
- Class II
- Quantity
- 207 units
- Official record key
device-enforcement:Z-1047-2019
Official wording
Reason: Breach in the sterile barrier pouch may compromise sterility of the device.
Code information: Lot Number/Exp. Date Z2458287A 2018-06-01; Z2458379A 2018-10-01
Distribution pattern: US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Derived failure modes
-
Sterility assurance
Breach in the sterile barrier