FDA-Device2016-08-31Class II
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.
Integra LifeSciences Corp.
Hazard
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Sold states
US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
Affected count
120 units from multiple lots
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2600-2016Don't want to check this manually?
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