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 is…
- Recall date
- July 21, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2600-2016
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp.
- Sold / distributed
- US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
Why it was recalled
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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