Reported Feb 6, 2013 · Terminated
Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to…
Extremity Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Extremity Medical LLC · 300 Interpace Pkwy Ste 410A · Parsippany, NJ · 07054-1148
Is this the product you have?
- 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. Orthopedic device.
- Lot codes and dates
- Catalog Number 101-00010 Lot number
AP3V12AP4E01AP4N04AP5E25AP6A44AP6E42AP6L14AP6M17AP6T08
- Catalog Number 101-00010 Lot number
- Amount recalled
- 93 units
Where it was sold
Why it was recalled
Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
This product could cause temporary or reversible health problems — stop using it.
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