• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IO FIX IntraOsseous Fixation

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
IO FIX IntraOsseous Fixation
see related information
Date Posted November 18, 2012
Recall Status1 Terminated on March 21, 2013
Recall Number Z-0344-2013
Recall Event ID 62916
Premarket Notification
510(K) Number
K101700 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Code Information Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620.
Recalling Firm/
Manufacturer
Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany, New Jersey 07054-1148
For Additional Information Contact Mr. Jeffrey Zoleta
973-588-8980
Manufacturer Reason
for Recall
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.
Quantity in Commerce 120 Units
Distribution Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.
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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = EXTREMITY MEDICAL LLC
-
-