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U.S. Department of Health and Human Services

Class 2 Device Recall Avitus

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 Class 2 Device Recall Avitussee related information
Date Initiated by FirmFebruary 18, 2019
Create DateMarch 23, 2019
Recall Status1 Terminated 3 on April 22, 2020
Recall NumberZ-1046-2019
Recall Event ID 82271
510(K)NumberK152474 
Product Classification Instrument, biopsy - Product Code KNW
ProductAvitus 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
Code Information Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01
FEI Number 3011504993
Recalling Firm/
Manufacturer		 Avitus Orthopaedics, Inc.
400 Farmington Ave Ste 2826
Farmington CT 06032-1913
Manufacturer Reason
for Recall		Breach in the sterile barrier pouch may compromise sterility of the device.
FDA Determined
Cause 2		Packaging process control
ActionThe 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.
Quantity in Commerce508 units
DistributionUS Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNW
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