Arrow International Inc: Medical Device Recall in 2021 - (Recall #: Z-1374-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 8, 2021

Date Posted: April 14, 2021

Recall Number: Z-1374-2021

Event ID: 87499

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

Status: Ongoing

Product Quantity: 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS

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.

Voluntary or Mandated:

Voluntary: Firm initiated