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Recall Observatory FDA recall evidence

Device 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 intended to harvest cancellous bone and bone marrow

Z-1047-2019

February 18, 2019

Class II

Product summary

Firm
Avitus Orthopaedics, Inc.
Event
Event 82271
Status
Terminated
Classification
Class II
Quantity
207 units
Official record key
device-enforcement:Z-1047-2019

Official wording

Reason: Breach in the sterile barrier pouch may compromise sterility of the device.

Code information: Lot Number/Exp. Date Z2458287A 2018-06-01; Z2458379A 2018-10-01

Distribution pattern: US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Breach in the sterile barrier