Z-1374-2021 Class II Ongoing
FDA device recall Z-1374-2021 was initiated by Arrow International Inc on March 8, 2021 and is designated Class II. 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 biop… The recall status is ongoing. Affected quantity: 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 8, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Product Description
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740