CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
Avitus¿ Bone Harvester w/ Filter Insert recalled by Avitus Orthopaedics
Avitus Orthopaedics is recalling Avitus¿ Bone Harvester w/ Filter Insert - intended to harvest cancellous bone and bone, distributed nationwide in the US. The recall was initiated on 18 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1047-2019
- FDA event ID
- 82271
- Recalling firm
- Avitus Orthopaedics, Farmington, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Feb 2019
- FDA classified
- 22 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Feb 2019 | Recall initiated by company | |
| 22 Mar 2019 | Classified by FDA | +32 days |
| 3 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Breach in the sterile barrier pouch may compromise sterility of the device.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
Nationwide ArizonaCaliforniaConnecticutFloridaMarylandMichiganNew MexicoOhioPennsylvania
Questions about this recall
Is Avitus¿ Bone Harvester w/ Filter Insert - intended to harvest cancellous bone and bone recalled?
Yes. Avitus Orthopaedics recalled Avitus¿ Bone Harvester w/ Filter Insert - intended to harvest cancellous bone and bone on 18 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1047-2019.
Why was it recalled?
Breach in the sterile barrier pouch may compromise sterility of the device.
Which lots are affected?
Lot Number/Exp. Date Z2458287A 2018-06-01; Z2458379A 2018-10-01
Where was it sold?
US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avitus Orthopaedics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Avitus¿ Bone Harvester w/ Filter Insert recalled by Avitus Orthopaedics | Avitus Orthopaedics | Sterility | Nationwide |
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