FDAFDA · Food and drugs·Recall number Z-1823-2015
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Published July 1, 2015 · Recall initiated: April 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- X Spine Systems Inc
- Distributor
- Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
- Lot
- Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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