Arrow OnControl Bone Lesion Biopsy System Recalled for Insertion Defect
Arrow International is recalling OnControl Bone Lesion Biopsy Systems because the ejector rod may not insert properly, preventing sample collection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (prolonged procedure and need for repeat biopsy) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling the Arrow OnControl Bone Lesion Biopsy System, specifically the 11 ga 10 cm Access/13 ga 14 cm Biopsy configuration. The recall affects 3,756 units distributed in the United States and 249 units sold in other regions. Specific lot numbers for the US include 39647326, 39647327, 39647328, 40422734, and 40422735, while the EU lot number is 40808740. An expanded recall on May 4, 2021, added lot numbers 38347967 and 40422740.
The recall is due to a defect where the biopsy ejector rod may have difficulty inserting into the bone lesion biopsy cannula. This issue prevents the biopsy sample from being collected. The use of a defective device is likely to require an immediate repeat biopsy, which leads to a prolonged procedure.
The device is intended for bone biopsy of the vertebral body and bone lesions. The recall is classified as Class II by the FDA. Healthcare providers should stop using the affected devices and contact Arrow International for further instructions.
The recalled product
- 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.
- Manufacturer
- Arrow International Inc
Distribution
Distributed nationwide across the United States.
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