Z-0952-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- January 10, 2013
- Termination Date
- July 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 238 units
Product Description
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.
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.
Distribution Pattern
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.
Code Information
Catalog Number 101-00006; Lot Number 00921538.