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
FDA Recall Z-1047-2019 · Posted None
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Recalling FirmAvitus Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2019-02-18
Date Terminated2020-04-22
Product Quantity207 units
Reason for Recall
Breach in the sterile barrier pouch may compromise sterility of the device.
Firm 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].
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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