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Recall Observatory FDA recall evidence

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

October 30, 2012

Class II

Product summary

Firm
Orthohelix Surgical Designs Inc
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

    reason.no_named_rule · v1.0.0

    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.