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Integra LifeSciences Corp. recalls Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw
Recalled August 31, 2016 · FDA recall Z-2600-2016 · Integra LifeSciences
Hazard
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw". · FDA Class II
Units
120 units from multiple lots
Sold at
US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
Description
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Product
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →