Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13… — Class II medical device recall Z-1374-2021
Ongoing recall by Arrow International Inc, reported 2021-04-14, distributed nationwide. Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample
| Recall number | Z-1374-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2021-03-08 |
| Classified | 2021-04-07 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Lot numbers | 38347967, 39647326, 39647327, 39647328, 40422734, 40422735, 40422740, 40808740 |
Product
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
Reason for recall
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
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-1374-2021. 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.