Home / Recalls / Orthohelix Surgical Designs Inc / Z-0975-2013

Z-0975-2013 Class II Terminated

Recalled by Orthohelix Surgical Designs Inc — Medina, OH

Recall Details

Product Type: Devices
Report Date: April 3, 2013
Initiation Date: October 30, 2012
Termination Date: December 5, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs

Product Description

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.

Reason for Recall

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.

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.

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.