ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Reported: December 7, 2016 Initiated: November 8, 2016 #Z-0677-2017
Product Description
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Reason for Recall
Sterility: Due to a potential incomplete seal on the outer sterile package.
Details
- Recalling Firm
- Teleflex Medical
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.. Recalled by Teleflex Medical.
Why was this product recalled? ▼
Sterility: Due to a potential incomplete seal on the outer sterile package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0677-2017.
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