Device 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.
Z-1374-2021
Product summary
- Event
- Event 87499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
- Official record key
device-enforcement:Z-1374-2021
Official wording
Reason: 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
Code information: Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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