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U.S. Department of Health and Human Services

Class 2 Device Recall Intraosseous Fixation System

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 Class 2 Recall
Intraosseous Fixation System
see related information
Date Posted March 22, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0975-2013
Recall Event ID 64485
Product Classification Bit, Drill - Product Code HTW
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.
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.
Recalling Firm/
Manufacturer
Orthohelix Surgical Designs Inc
1065 Medina Rd Ste 500
Medina, Ohio 44256-5376
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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