Recall Z-1047-2019 ยท KNW Instrument, Biopsy
Avitus Orthopaedics, Inc.
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
| Date | Feb 18, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 207 units |
| Distribution | US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - Avitus Orthopaedics, Inc., Mar 20, 2017 |