FDA-Device2013-04-03Class II
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.
Orthohelix Surgical Designs Inc
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.
Sold states
Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
Affected count
Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs
Manufactured in
1065 Medina Rd Ste 500, Medina, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0975-2013Don't want to check this manually?
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