Extremity Medical Recalls Undersized 1.6 mm Orthopedic Guidewires
Extremity Medical LLC is recalling 238 non-sterile 1.6 mm guidewires because they are undersized, causing depth gauge readings to select screws approximately 2 mm longer than intended.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that leads to the selection of an incorrect screw size (2 mm longer than intended), which poses a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Extremity Medical LLC is recalling 238 units of the 1.6 mm Guidewire (Reference Number 101-00006, Lot Number 00921538). These non-sterile disposable orthopedic surgical instruments are contained in Extremity Medical Surgical Kits, including CompressX, Hallu.X, IO Fix, and XMCP. The product is used in the selection of screw size when used with an appropriate depth gauge.
The recall is being issued because the 1.6 mm Guidewire is undersized by up to 2 mm in length. When used with the depth gauge, the measurement reading does not correspond with the desired screw length. Consequently, the selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
The affected units were distributed worldwide, including in the United States (Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York, and Tennessee) and in Australia, Belgium, Israel, the Netherlands, and the United Kingdom. Users should stop using the affected guidewires and contact Extremity Medical LLC for instructions on return or replacement.
The recalled product
- 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 appropriat
- Manufacturer
- Extremity Medical LLC
- Affected units
- 238
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number 101-00006
- Lot Number 00921538.
Distribution
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