Extremity Medical Recalls IO FiX System Screw Measuring Device
Extremity Medical LLC is recalling 93 units of the IO FiX System Accessory screw measuring device because it may measure screw length approximately 5 mm short, potentially leading to the selection of an inappropriate implant size.
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 can lead to the selection of an inappropriate implant size, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Extremity Medical LLC is recalling 93 units of the IO FiX System Accessory, Catalog Number 101-00010. This orthopedic device is used to measure the length of screws for the IO FiX Screw and Washer System by placing a depth gauge over a guidewire and down to the bone. The affected lots are AP3V12, AP4E01, AP4N04, AP5E25, AP6A44, AP6E42, AP6L14, AP6M17, and AP6T08.
The recall was initiated because the screw measuring device may measure the lag screw length approximately 5 mm shorter than the actual length when used according to the IO FIX Surgical Technique Rev C. This measurement error can lead to the selection of an inappropriate implant size, such as choosing a screw that is too short for the procedure.
The affected products were distributed worldwide and nationwide in the United States, including Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Maryland, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Wisconsin, and Washington. Healthcare providers and patients should contact Extremity Medical LLC for further instructions regarding the return or replacement of the device.
The recalled product
- Product
- Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthop
- Manufacturer
- Extremity Medical LLC
- Affected units
- 93
Distribution
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