FDA-Device2021-04-14Class II
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.
Arrow International Inc
Hazard
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
Sold states
US Nationwide distribution.
Affected count
3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2021Don't want to check this manually?
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