FDAFDA · Food and drugs·Recall number Z-0975-2013
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Published April 3, 2013 · Recall initiated: October 30, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthohelix Surgical Designs Inc
- Distributor
- Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
- Lot
- Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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