Recall Z-1046-2019
Avitus Orthopaedics, Inc. · initiated February 18, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01
Reason for recall
Breach in the sterile barrier pouch may compromise sterility of the device.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1046-2019
- Initiated
- February 18, 2019
- Terminated
- April 22, 2020
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 508 units
- Distribution
- US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
- Recalling firm
- Avitus Orthopaedics, Inc., Farmington, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1047-2019 Class II | Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and…Breach in the sterile barrier pouch may compromise sterility of the device. | 02/18/2019Terminated |