Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixati

FDA device recall Z-0975-2013 · posted 2013-03-22 · Terminated

Recall details

Recalling firm

Orthohelix Surgical Designs Inc

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.

Action taken

OrthoHelix sent a "FIELD REMOVAL NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 330-247-1444 for questions concerning this notice.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HTW

Quantity affected

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

Distribution

Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.

Date initiated

2012-10-30

Date posted

2013-03-22

Date terminated

2013-12-05

Location

Medina, OH