The Recall Desk
HighFDA (Devices)·Z-0677-2017·Announced 2016-12-07

Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays

Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.

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 involves a potential sterility failure in a medical device used for invasive procedures, which poses a risk of harm, but no injuries or illnesses have been reported.

Plain-English summary

Teleflex Medical is recalling the Arrow OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only. The recall is due to a potential incomplete seal on the outer sterile package. The system is intended for bone biopsy of the vertebral body and bone lesions.

The affected products were distributed worldwide, including the United States, Brazil, Canada, Ecuador, Guatemala, Mexico, and Peru. The recall covers specific material numbers and lot numbers, including 9461-VC-001, 9461-VC-006, 9462-VC-001, 9462-VC-006, 9463-VC-001, 9463-VC-006, 9464-VC-001, 9464-VC-006, 9465-VC-001, 9465-VC-006, 9466-VC-001, and 9466-VC-006.

Healthcare providers should stop using the affected trays and contact Teleflex Medical for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
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.
Manufacturer
Teleflex Medical
Category
Medical Device — Surgical Instruments
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Material # 9461-VC-001
  • Lot numbers: 012579S
  • 013469S
  • 011227 & 011492
  • Material # 9461-VC-006
  • 011938
  • 012694
  • 013065
  • 013686 & 014615
  • Material # 9462-VC-001
  • Lot numbers: 010743S
  • 10778S
  • 010954S
  • 012580S & 012891S
  • Material # 9462-VC-006
  • Lot numbers: 010444
  • 010743
  • 010778
  • 010954
  • 011495

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · sterility failure

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