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Terminated

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

FDA Recall Z-1046-2019 · Posted None

Recalling FirmAvitus Orthopaedics, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2019-02-18
Date Terminated2020-04-22
Product Quantity508 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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