Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended recall: Sterility Concern
Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is…
Why was Avitus¿ Bone Harvester w/ Filter Insert - 5mm 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 Z2458287A 2018-06-01; Z2458379A 2018-10-01
- Product
- Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is…
- Recalling firm
- Avitus Orthopaedics, Inc.
- Quantity
- 207 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)