Avitus¿ Bone Harvester w/ Filter Insert — Class II medical device recall Z-1046-2019
Terminated recall by Avitus Orthopaedics, Inc., reported 2019-04-03, distributed nationwide. Breach in the sterile barrier pouch may compromise sterility of the device.
| Recall number | Z-1046-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avitus Orthopaedics, Inc., Farmington, CT, United States |
| Recall initiated | 2019-02-18 |
| Classified | 2019-03-22 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR |
| Quantity | 508 units |
| Reason classes | sterility |
| Lot numbers | Z2458218A, Z2458253B, Z2458379B, Z2458448B |
| Model numbers | BH-110 |
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 intended to harvest cancellous bone and bone marrow
Reason for recall
Breach in the sterile barrier pouch may compromise sterility of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1046-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.