Orthohelix Surgical Designs Inc: Medical Device Recall in 2013 - (Recall #: Z-0975-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 30, 2012

Date Posted: April 3, 2013

Recall Number: Z-0975-2013

Event ID: 64485

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.

Status: Terminated

Product Quantity: Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs

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.

Voluntary or Mandated:

Voluntary: Firm initiated