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U.S. Department of Health and Human Services

Class 2 Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire

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 Class 2 Recall
Extremity Medical Disposable Instrument 1.6 mm Guidewire
see related information
Date Posted March 15, 2013
Recall Status1 Terminated on July 18, 2013
Recall Number Z-0952-2013
Recall Event ID 64330
Product Classification Passer, Wire, Orthopedic - Product Code HXI
Product Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
Code Information Catalog Number 101-00006; Lot Number 00921538.
Recalling Firm/
Manufacturer
Extremity Medical LLC
300 Interpace Pkwy Ste 410A
Parsippany, New Jersey 07054-1148
For Additional Information Contact Mr. Brian A. Smekal
973-588-8988
Manufacturer Reason
for Recall
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
FDA Determined
Cause 2
DESIGN: Device Design
Action Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.
Quantity in Commerce 238 units
Distribution Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
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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