Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended recall: Sterility Concern
Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is…
Why was Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended recalled?
Breach in the sterile barrier pouch may compromise sterility of the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01
- 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…
- Recalling firm
- Avitus Orthopaedics, Inc.
- Quantity
- 508 units
- Distribution
- US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
- Recall date
- April 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)