Device product
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.
Z-0975-2013
Product summary
- Event
- Event 64485
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs
- Official record key
device-enforcement:Z-0975-2013
Official wording
Reason: 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.
Code information: Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.
Distribution pattern: Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
Derived failure modes
-
Unknown
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.